title: Commission Directive 2007/28/EC of 25 May 2007 amending certain Annexes to Council Directives 86/363/EEC and 90/642/EEC as regards maximum residue levels for azoxystrobin, chlorfenapyr, folpet, iprodione, lambda-cyhalothrin, maleic hydrazide, metalaxyl-M and trifloxystrobin (Text with EEA relevance)

text:
               26.5.2007

               EN

               Official Journal of the European Union

               L 135/6

      COMMISSION DIRECTIVE 2007/28/EC
   of 25 May 2007
   amending certain Annexes to Council Directives 86/363/EEC and 90/642/EEC as regards maximum residue levels for azoxystrobin, chlorfenapyr, folpet, iprodione, lambda-cyhalothrin, maleic hydrazide, metalaxyl-M and trifloxystrobin
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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 (1), 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 (2), and in particular Article 7 thereof,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof,
   Whereas:

               (1)

               In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops.

               (2)

               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.

               (3)

               MRLs for pesticides covered by Directives 86/363/EEC and 90/642/EEC are to be kept under review and may be modified to take account of 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 azoxystrobin, chlorfenapyr, folpet, iprodione, lambda-cyhalothrin, maleic hydrazide, metalaxyl-M and trifloxystrobin.

               (4)

               The lifetime exposure of consumers to those pesticides via food products that may contain residues of those pesticides has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (4). Based on those assessments and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded.

               (5)

               In the case of chlorfenapyr, folpet and lambda-cyhalothrin for which an acute reference dose (ARfD) exists, the acute exposure of consumers via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the Community, taking account of guidelines published by the World Health Organisation. The opinions of the Scientific Committee on Plants (SCP), in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides (5), have been taken into account. Based on the dietary intake assessment, the MRLs for those pesticides should be fixed so as to ensure that the ARfD will not be exceeded. In the case of the other substances, an assessment of the available information has shown that no ARfD is required and that therefore a short-term assessment is not needed.

               (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)

               The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for maleic hydrazide and trifloxystrobin in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI to that Directive. It is considered that a period of four years is sufficient to permit further uses of these substances. The provisional Community MRLs should then become definitive.

               (8)

               It is therefore necessary to modify the MRLs set out in the Annexes to Directives 86/363/EEC and 90/642/EEC, to allow for proper surveillance and control of the uses of the concerned plant protection products 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 yet been defined, it is appropriate to set them for the first time.

               (9)

               Directives 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 86/363/EEC is amended in accordance with Annex I to this Directive.
   Article 2
   Directive 90/642/EEC is amended in accordance with Annex II to this Directive.
   Article 3
   1.   Member States shall adopt and publish, by 26 November 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 27 November 2007.
   When Member States adopt those provisions they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 25 May 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2007/27/EC (OJ L 128, 16.5.2007, p. 31).

      (2)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2007/27/EC.

      (3)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).

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

      (5)  Opinion regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the SCP on 14 July 1998); Opinion regarding variable pesticide residues in fruit and vegetables (Opinion expressed by the SCP on 14 July 1998); http://europa.eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html

      ANNEX I
      In Part B of Annex II to Directive 86/363/EEC, the following line is added:

                     Maximum levels in mg/kg

                     Pesticide residues

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

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

                     of shelled fresh eggs, for birds’ eggs and egg yolks listed in Annex I under heading Nos 0407 and 0408

                     ‘Maleic hydrazide (2)

                     meat (except poultry) 0,05 (3)

                     liver (except poultry) 0,05 (3)

                     kidney (except poultry) 0,5 (3)

                     others 0,02 (1)
                         (3)

                     0,2 (3)
                         (4)

                     0,1 (3)

         (1)  Indicates lower limit of analytical determination.

         (2)  Residue definition for milk and milk products is: maleic hydrazide and its conjugates expressed as maleic hydrazide.

         (3)  Indicates that the maximum residue level has been established provisionally in accordance with Article 4(1)(f) of Directive 91/414/EEC.

         (4)  Indicates that the maximum residue level has been established temporarily until 30 June 2008 pending data to be submitted by the applicant. If no data has been received by that date, the MRL will be withdrawn by a Directive or a Regulation.’

      ANNEX II
      In part A of Annex II to Directive 90/642/EEC, the columns for azoxystrobin, chlorfenapyr, folpet, iprodione, lambda-cyhalothrin, maleic hydrazide, metalaxyl and trifloxystrobin are replaced by the following:

                     Pesticide residue and maximum residue level (mg/kg)

                     Groups and examples of individual products to which the MRLs apply

                     Azoxystrobin

                     Chlorfenapyr

                     Folpet

                     Iprodione

                     Lambda-cyhalothrin

                     Maleic Hydrazide

                     Metalaxyl including other mixtures of constituent isomers including metalaxyl-M (sum of isomers)

                     Trifloxystrobin

                                 ‘1.

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

                     0,05 (1)

                     0,2 (1)
                         (3)

                                 (i)

                                 CITRUS FRUIT

                     1

                     0,02 (1)

                     0,5

                     0,3 (3)

                     Grapefruit

                     0,1

                     Lemons

                     5 (3)

                     0,2

                     Limes

                     0,2

                     Mandarins (including clementines and other hybrids)

                     1 (3)

                     0,2

                     Oranges

                     0,1

                     Pomelos

                     0,1

                     Others

                     0,02 (1)
                         (3)

                     0,02 (1)

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,1 (1)

                     0,02 (1)

                     0,05 (1)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     0,2 (3)

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     Others

                     0,02 (1)
                         (3)

                                 (iii)

                                 POME FRUIT

                     0,05 (1)

                     3 (2)

                     5 (3)

                     0,1

                     1

                     0,5 (3)

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     0,05 (1)

                     3 (3)

                     0,05 (1)

                     Apricots

                     0,2

                     1 (3)

                     Cherries

                     2

                     1 (3)

                     Peaches (including nectarines and similar hybrids)

                     0,2

                     1 (3)

                     Plums

                     0,2 (3)

                     Others

                     0,02 (1)

                     0,1

                     0,02 (1)
                         (3)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     2

                     10 (3)

                     0,2

                     5 (3)

                     Table grapes

                     0,02 (1)

                     2

                     Wine grapes

                     5

                     1

                                 (b)

                                 Strawberries (other than wild)

                     2

                     3 (2)

                     15 (3)

                     0,5

                     0,5

                     0,5 (3)

                                 (c)

                                 Cane fruit (other than wild)

                     10 (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     Blackberries

                     3

                     3 (2)

                     Dewberries

                     Loganberries

                     Raspberries

                     3

                     3 (2)

                     0,2

                     Others

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)

                                 (d)

                                 Other small fruit and berries (other than wild)

                     0,05 (1)

                     10 (3)

                     0,05 (1)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     3 (2)

                     0,1

                     1 (3)

                     Gooseberries

                     3 (2)

                     0,1

                     1 (3)

                     Others

                     0,02 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                                 (e)

                                 Wild berries and wild fruit

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,2

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (vi)

                                 MISCELLANEOUS

                     0,02 (1)

                     0,05 (1)

                     Avocados

                     Bananas

                     2

                     0,05 (3)

                     Dates

                     Figs

                     Kiwi

                     5 (3)

                     Kumquats

                     Litchis

                     Mangoes

                     0,2

                     0,1

                     Olives (table consumption)

                     0,5

                     Olives (oil extraction)

                     0,5

                     Papaya

                     0,2

                     1 (3)

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                                 2.

                                 Vegetables, fresh or uncooked, frozen or dry

                     0,05 (1)

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,02 (1)

                     Beetroot

                     Carrots

                     0,2

                     0,5 (3)

                     30 (3)

                     0,1

                     0,05 (3)

                     Cassava

                     Celeriac

                     0,3

                     0,1

                     Horseradish

                     0,2

                     0,5 (3)

                     0,1

                     Jerusalem artichokes

                     Parsnips

                     0,2

                     0,5 (3)

                     30 (3)

                     0,1

                     Parsley root

                     0,2

                     0,5 (3)

                     Radishes

                     0,2

                     0,3 (3)

                     0,1

                     0,1

                     Salsify

                     0,2

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,2 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (ii)

                                 BULB VEGETABLES

                     0,2 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Garlic

                     0,2 (3)

                     15 (3)

                     0,5

                     Onions

                     0,1

                     0,2 (3)

                     15 (3)

                     0,5

                     Shallots

                     0,2 (3)

                     15 (3)

                     0,5

                     Spring onions

                     2

                     3 (3)

                     0,05

                     0,2

                     Others

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,2 (1)
                         (3)

                     0,05 (1)

                                 (iii)

                                 FRUITING VEGETABLES

                     0,2 (1)
                         (3)

                                 (a)

                                 Solanacea

                     2

                     5 (3)

                     Tomatoes

                     2 (2)

                     0,1

                     0,2

                     0,5 (3)

                     Peppers

                     0,1

                     0,5

                     Aubergines

                     0,5

                     Okra

                     0,1

                     Others

                     0,02 (1)

                     0,02 (1)

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (b)

                                 Cucurbits — edible peel

                     1

                     0,02 (1)

                     2 (3)

                     0,1

                     0,2 (3)

                     Cucumbers

                     0,5

                     Gherkins

                     Courgettes

                     Others

                     0,05 (1)

                                 (c)

                                 Cucurbits — inedible peel

                     0,5

                     1

                     1 (3)

                     0,05

                     Melons

                     0,2

                     0,3 (3)

                     Squashes

                     Watermelons

                     0,2

                     0,2

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (d)

                                 Sweetcorn

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,05

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,2 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (a)

                                 Flowering brassica

                     0,5

                     0,02 (1)

                     0,1 (3)

                     0,1

                     0,2

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     0,3

                     0,02 (1)

                     Brussels sprouts

                     0,5 (3)

                     0,05

                     Head cabbage

                     5 (3)

                     0,2

                     1

                     Others

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,05 (1)

                                 (c)

                                 Leafy brassica

                     5

                     0,02 (1)

                     1

                     Chinese cabbage

                     5 (3)

                     Kale

                     0,2

                     Others

                     0,02 (1)
                         (3)

                     0,05 (1)

                                 (d)

                                 Kohlrabi

                     0,2

                     0,05

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,05 (1)

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,2 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (a)

                                 Lettuce and similar

                     3

                     10 (3)

                     Cress

                     Lamb's lettuce

                     0,2

                     Lettuce

                     2

                     0,5

                     2

                     Scarole (broad-leaf endive)

                     1

                     Ruccola

                     Leaves and stems of brassica, including turnip greens

                     Others

                     0,02 (1)

                     1

                     0,05 (1)

                                 (b)

                                 Spinach and similar

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,5

                     0,05 (1)

                     Spinach

                     10

                     Beet leaves (chard)

                     Others

                     0,02 (1)

                                 (c)

                                 Watercress

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,05 (1)

                                 (d)

                                 Witloof

                     0,2

                     0,02 (1)

                     2 (3)

                     0,02 (1)

                     0,3

                                 (e)

                                 Herbs

                     3

                     0,02 (1)

                     10 (3)

                     1

                     2

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,2 (1)
                         (3)

                     0,05 (1)

                     Beans (with pods)

                     1

                     2 (2)

                     5 (3)

                     0,2

                     0,5 (3)

                     Beans (without pods)

                     0,2

                     2 (2)

                     Peas (with pods)

                     0,5

                     2 (3)

                     0,2

                     Peas (without pods)

                     0,2

                     0,3 (3)

                     0,2

                     Others

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,02 (1)

                     0,2 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Asparagus

                     Cardoons

                     Celery

                     5

                     0,3

                     Fennel

                     0,3

                     Globe artichokes

                     1

                     Leek

                     2

                     0,3

                     0,2

                     Rhubarb

                     0,2 (3)

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,05 (1)

                                 (viii)

                                 FUNGI

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,2 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (a)

                                 Cultivated mushrooms

                     0,02 (1)

                                 (b)

                                 Wild mushrooms

                     0,5

                                 3.

                                 Pulses

                     0,1

                     0,05 (1)

                     0,02 (1)

                     0,2 (3)

                     0,02 (1)

                     0,2 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

                                 4.

                                 Oilseeds

                     0,1 (1)

                     0,05 (1)

                     0,05 (1)

                     0,5 (1)
                         (3)

                     0,1 (1)

                     0,05 (1)
                         (3)

                     Linseed

                     0,5 (3)

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     0,5 (3)

                     Rapeseed

                     0,5

                     0,5 (3)

                     Soya bean

                     0,5

                     Mustard seed

                     Cotton seed

                     Hemp seed

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 5.

                                 Potatoes

                     0,05 (1)

                     0,05 (1)

                     0,1

                     0,02 (1)
                         (3)

                     0,02 (1)

                     50 (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     Early potatoes

                     Ware potatoes

                                 6.

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

                     0,1 (1)

                     50

                     0,05 (1)

                     0,1 (1)
                         (3)

                     1

                     0,5 (1)
                         (3)

                     0,1 (1)

                     0,05 (1)
                         (3)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     20

                     0,1 (1)

                     150

                     0,1 (1)
                         (3)

                     10

                     0,5 (1)
                         (3)

                     10

                     30 (3)

         (1)  Indicates lower limit of analytical determination.

         (2)  Sum of captan and folpet.

         (3)  Indicates that the maximum residue level has been established provisionally in accordance with Article 4(1)(f) of Directive 91/414/EEC.’


Avis juridique important

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31980L0393

Council Directive 80/393/EEC of 18 March 1980 amending the Annexes to Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products

Official Journal L 100 , 17/04/1980 P. 0035 - 0046 Greek special edition: Chapter 03 Volume 33 P. 0135  Spanish special edition: Chapter 03 Volume 17 P. 0227  Portuguese special edition Chapter 03 Volume 17 P. 0227

COUNCIL DIRECTIVE  of 18 March 1980  amending the Annexes to Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products  (80/393/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), and in particular Article 13 thereof,  Having regard to the prosposal from the Commission,  Whereas, in the interests of a uniform implementation of Directive 77/93/EEC the term "harmful viruses and mycoplasmas" of fruit plants (in particular Annex I (A) (e) (1)) should be clarified at Community level ; whereas, therefore, an amendment to Annex I (A) (e) and to Annex II (A) (d) is necessary ; whereas the "special requirements" (Annex IV (A)) established in regard to the harmful organisms concerned should be adapted accordingly;  Whereas any risk should be prevented which may arise from the introduction on potato breeding material, of harmful organisms unknown in the Community ; whereas, therefore, the protective measures laid down in this connection in Annex III (A) should be extended;  Whereas the measures laid down in the said Directive in the case of oak wood in the round, against the introduction of oak wilt (Ceratocystis fagacearum) into the Community have on the one hand proved insufficient, and on the other unnecessarily strict ; whereas therefore, the "special requirements" established in respect of this disease (Annex IV (A) (2)) should take into account the technical safeguards which have been recognized since then;  Whereas it is appropriate, furthermore, to clarify certain provisions of the Annexes to the Directive and to eliminate some ambiguities,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex I to Directive 77/93/EEC is hereby amended as follows:    1. The following items shall be added to A (a):  " 17. Arrhenodes minutus Drury,   18.  Pseudopityophthorus minutissimus Zimm.,   19.  Pseudopityophthorus pruinosus Eichh.";       2. (A) (e) (1) shall be replaced by the following:  "1. Harmful viruses and harmful virus-like pathogens of Cydonia Mill., Fragaria (Tourn.) L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L.:      (a) apple proliferation mycoplasm,           (b) apricot chlorotic leafroll mycoplasm,           (c) cherry raspleaf virus (American),           (d) peach mosaic virus (American),           (e) peach phony rickettsia,  (1)OJ No L 26, 31.1.1977, p. 20.            (f) peach rosette mycoplasm,           (g) peach yellows mycoplasm,           (h) pear decline mycoplasm,           (i) plum line pattern virus (American),  (k)  raspberry leaf curl virus (American),  (l)  sharka virus,  (m)  strawberry latent "C" virus,  (n)  strawberry vein-banding virus,  (o)  strawberry witches' broom pathogen,  (p)  X-disease mycoplasm,  (q)  other harmful viruses and harmful virus-like pathogens, in so far as they do not exist in the Community.";                  3. In (B) (c) (6) and (7), the words "United Kingdom (Northern Ireland)" shall be added in the right-hand column.          Article 2 Annex II to Directive 77/93/EEC is hereby amended as follows:    1. In (A) (a) (9), the text of the right-hand column shall be replaced by the following:  "Wood of conifers (coniferae), with bark, originating in non-European countries";       2. In the English version of (A) (c) (3), the words "Irish rhizomes" shall be replaced by "Iris bulbs";       3. In the English version of (A) (c) (10), the words "Flower corms" shall be replaced by "Flower bulbs";       4. In the Italian version of (A) the third table shall be entitled "(c) Crittogame" instead of "(d) Virus e micoplasmi";       5. (A) (d) shall be replaced by the following:  "(d) Viruses and virus-like pathogens: >PIC FILE= "T0013225">    >PIC FILE= "T0013226">        6. In (B) (c) (7), the words "United Kingdom (Northern Ireland)" shall be added in the right-hand column.          Article 3 Annex III to Directive 77/93/EEC is hereby amended as follows: >PIC FILE= "T0013227">    >PIC FILE= "T0013228">   5. In (B) (7), the words "United Kingdom (Northern Ireland)" shall be added in the right-hand column.   Article 4 Annex IV of Directive 77/93/EEC is hereby amended as follows: >PIC FILE= "T0013229">    4. In the German version of (A) (4), the word "oder" shall be added in the right-hand column between the text of (a) and that of (b); >PIC FILE= "T0013231">   6. In (A) (7) (a), (8) to (11) and (12) (a), the words "or in its immediate vicinity" shall be added each time after the words "at the place of production";  7. In (A) (9) (a), the second indent shall be deleted in the right-hand column;  8. In (A) (14), the words "the Ulmaceae family" shall be replaced by "Ulmus and Zelkova"; >PIC FILE= "T0013232">    >PIC FILE= "T0013233">    >PIC FILE= "T0013234">    >PIC FILE= "T0013235">    >PIC FILE= "T0013236">    >PIC FILE= "T0013237">    >PIC FILE= "T0013238">   13. In the English version of IV (A) (30), the words "and have been found free" shall be replaced by "which have been found free"; >PIC FILE= "T0013239">   15. In (A) (38), the words "and that no symptoms have been" shall be replaced by "and that no Ditylenchius dipsaci has been";  16. In (B) (12) and (13), the words "United Kingdom (Northern Ireland)" shall be added in the right-hand column.   Article 5 Annex V to Directive 77/93/EEC is hereby amended as follows:    1. In (4) the first indent shall be replaced by the following:  "- Castanea, Quercus, including - where it originates in North American countries - wood which does not retain its natural round surface,   - Ulmus";      2. The following shall be inserted:  "4a. Isolated bark of Quercus L., other than Quercus suber L."          Article 6 In the English version of Annex VIII (B) the title of the certificate shall be replaced by the following:  "RE-FORWARDING PHYTOSANITARY CERTIFICATE".    Article 7 Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with:    - Article 4 (11) by 1 January 1983 at the latest,       - the other provision of this Directive by 1 May 1980 at the latest.          Article 8 This Directive is addressed to the Member States.     Done at Brussels, 18 March 1980.  For the Council  The President  A. RUFFINI


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31986L0029

Second Commission Directive 86/29/EEC of 5 February 1986 amending Commission Directive 85/429/EEC amending the annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 039 , 14/02/1986 P. 0055 - 0056 Finnish special edition: Chapter 3 Volume 20 P. 0098  Swedish special edition: Chapter 3 Volume 20 P. 0098

*****SECOND  COMMISSION DIRECTIVE  of 5 February 1986  amending Commission Directive 85/429/EEC amending the annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs  (86/29/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by the Commission Directive 85/520/EEC (2), and in particular Article 7 thereof,  Whereas Directive 70/524/EEC provides for regular adaptation of the content of its Annexes to the evolution of scientific and technical knowledge;  Whereas progress in the analytical field allows the chemical composition of the antibiotic factors of tylosine to be specified and the admission of this additive to be limited to tylosine phosphate;  Whereas the use of the antibiotic flavophospholipol has been widely and successfully tested on rabbits in certain Member States, it is desirable to admit this new use of flavophospholipol provisionally at a national level until its authorization on a Community level;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs;  HAS ADOPTED THIS DIRECTIVE:  Article 1  The annexes of Directive 70/524/EEC shall be amended as set out in the annex hereto.  Article 2  Member States shall, by 3 December 1986 bring into force the laws, regulations or administrative provisions necessary to comply with Article 1, and shall immediately inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 5 February 1986.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No L 270, 14. 12. 1970, p. 1.  (2) OJ No L 323, 4. 12. 1985, p. 12.  ANNEX  1. In Annex I under part A 'Antibiotics' the text of item EEC No E 713 'Tylosine' is replaced at follows:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 // E 713  // Tylosin phosphate   // Macrolide, product of Streptomyces fradiae   // Piglets Pigs   // 4 months 6 months   // 10 5  // 40 20   //   //   //   // Composition of antibiotic factor (1):   //   //   //   //   //   //   //   // (A) Tylosin C46H77NO17: min. 80 %   //   //   //   //   //   //   //  // (B) Desmycosin C39H65NO14   //   //   //   //   //   //  //   // (C) Macrocin C45H75NO17   //   //   //   //   //   //  //   // (D) Relomycin C46H79NO17   //   //   //   //   //  //   //   // (A) + (B) + (C) + (D): min.: 95 %   //   //   //  //   //   //    //   //   //   //   //   //   //  (1) According to the method of analysis of the British Pharmacopeia (Veterinary) 1985.'  2. In Annex II under part A 'Antibiotics' the following is added:  1.2.3.4.5.6.7.8.9 //  //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions  // Last day of validity 1.2.3.4.5.6,7.8.9 //  //  //  //  //  //  //  //  //  //  //  // //  // mg/kg  of complete feedingstuffs  //  //  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8.9 // 26   // Flavophospholipol   // C70H124O40N6P   // Rabbits  // -   // 2   // 4   // -   // 30. 11. 1987'   //    //   //  //   //   //   //   //   //


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31985L0405

Commission Directive 85/405/EEC of 11 July 1985 adapting to technical progress Council Directive 79/113/EEC on the approximation of the laws of the Member States relating to the determination of the noise emission of construction plant and equipment

Official Journal L 233 , 30/08/1985 P. 0009 - 0010 Spanish special edition: Chapter 13 Volume 19 P. 0013  Portuguese special edition Chapter 13 Volume 19 P. 0013  Finnish special edition: Chapter 15 Volume 7 P. 0048  Swedish special edition: Chapter 15 Volume 7 P. 0048

COMMISSION  DIRECTIVEof 11 July 1985adapting to technical progress Council Directive 79/113/EEC on the  approximation of the laws of the Member States relating to the determination of the noise emission  of construction plant and equipment(85/405/EEC)THE COMMISSION OF THE EUROPEAN  COMMUNITIES,Having regard to the Treaty establishing the European Economic Community,Having regard  to Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the Member  States relating to the determination of the noise emission of construction plant and equipment (1),  as last amended by Directive 81/1051/EEC (2), and in particular Articles 3, 4 and 5  thereof,Whereas, in view of experience gained and of the state of the art, it is now necessary to  match the requirements of Annex I and Annex II of Directive 79/113/EEC to the actual test  conditions;Whereas the measures provided for in this Directive are in accordance with the opinion  of the Committee on the Adaptation to Technical Progress of the Directive on the Determination of  the Noise Emission of Construction Plant and Equipment, HAS ADOPTED THIS DIRECTIVE:Article 1Annex I and Annex II to Directive  79/113/EEC are hereby amended in accordance with the Annex to this Directive.Article 2The Member  States shall, by 26 March 1986, adopt and publish the provisions required to comply with this  Directive and shall forthwith inform the Commission thereof.Article 3This Directive is addressed  to the Member States.Done at Brussels, 11 July 1985.For the CommissionStanley  CLINTON DAVISMember of the Commission(1) OJ N° L 33, 8. 2. 1979, p. 15. (2) OJ N° L 376, 30. 12. 1981, p. 49.  ANNEXAMENDMENTS TO ANNEX I TO DIRECTIVE 79/113/EEC5. MEASURING INSTRUMENTSPoint 5.2 shall be reworded as follows:5.2. Measuring instrumentsThe following instrument may be used to meet the preceding requirement:(aa  sound level meter which at least meets the requirements of IEC Publication 651, first edition, 1979  for the type of meters in Class 1. The meter must be used in the S response mode.Subparagrraph (b)  is not changed.In the comments under point 5.2 and under 5.3 and 5.4, the words 'IEC Publication  179, 1973 second edition' shall be replaced by 'IEC Publication 651, first edition, 1979'.7. MEASUREMENTS7.3.1. Detection of impulsive noiseThe phrase 'IEC Publication 179 A/1973', occuring between the second  and third line shall be replaced by: 'IEC Publication 651, first edition, 1979'.AMENDMENT TO ANNEX  II OF DIRECTIVE 79/113/EEC3. DEFINITIONS3.2Equivalent continuous sound pressure level LAeq(t1, t2)The words 'IEC Publication  179, 1973, second edition' in the second line shall be replaced by 'IEC Publication 651, first  edition, 1979'.


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31972L0277

Council Directive 72/277/EEC of 26 July 1972 concerning the details of publication of notices of public works contracts and concessions in the 'Official Journal of the European Communities'

Official Journal L 176 , 03/08/1972 P. 0012 Danish special edition: Series I Chapter 1972(III) P. 0784  English special edition: Series I Chapter 1972(III) P. 0823  Greek special edition: Chapter 06 Volume 1 P. 0139  Spanish special edition: Chapter 17 Volume 1 P. 0020  Portuguese special edition Chapter 17 Volume 1 P. 0020

++++( 1 ) OJ NO C 70 , 1 . 7 . 1972 , P . 38 .  ( 2 ) OJ NO C 79 , 20 . 7 . 1972 , P . 7 .  ( 3 ) OJ NO L 185 , 16 . 8 . 1971 , P . 5 .  ( 4 ) OJ NO C 82 , 16 . 8 . 1971 , P . 13 .  COUNCIL DIRECTIVE OF 26 JULY 1972 CONCERNING THE DETAILS OF PUBLICATION OF NOTICES OF PUBLIC WORKS CONTRACTS AND CONCESSIONS IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES  ( 72/277/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 57 ( 2 ) , 66 AND 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 ARTICLE 31 OF COUNCIL DIRECTIVE NO 71/305/EEC ( 3 ) OF 26 JULY 1971 CONCERNING THE COORDINATION OF PROCEDURES FOR THE AWARD OF PUBLIC WORKS CONTRACTS LAYS DOWN THAT THE COST OF PUBLICATION IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES OF THE NOTICES PROVIDED FOR UNDER ARTICLES 12 AND 19 SHALL BE DEFRAYED BY THE COMMUNITIES IN ACCORDANCE WITH THE PROCEDURE AND CONDITIONS PUBLISHED IN THE OFFICIAL JOURNAL ;  WHEREAS THE APPLICATION OF MEASURES ADOPTED BY THE COUNCIL IN RESPECT OF THE PUBLICATION OF NOTICES OF PUBLIC WORKS CONTRACTS IS MAINLY INTENDED TO INFORM INTERESTED PERSONS OF ALL IMPORTANT NOTICES AND THE NOTICES MUST THEREFORE BE PUBLISHED IN CONCISE TERMS ;  WHEREAS THE APPLICATION OF THESE MEASURES IS LIKELY TO HAVE CONSIDERABLE FINANCIAL IMPLICATIONS ON THE BUDGET ;  WHEREAS THE LENGTH OF THESE NOTICES SHOULD THEREFORE BE RESTRICTED ;  WHEREAS THE SAME LIMITATIONS SHOULD LIKEWISE APPLY TO NOTICES CONCERNING CONCESSIONS AND SUB-CONTRACTS REFERRED TO UNDER ITEM III OF THE DECLARATION OF 26 JULY 1971 OF REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES MEETING WITHIN THE COUNCIL CONCERNING PROCEDURES TO BE FOLLOWED IN THE FIELD OF PUBLIC WORKS CONCESSIONS ( 4 ) ;  WHEREAS IN ORDER TO ACHIEVE THE NECESSARY CONCISENESS , A UNIFORM PRESENTATION OF NOTICES OF PUBLIC WORKS CONTRACTS AND OF SUBCONTRACTS AWARDED BY CONCESSIONAIRES IS DESIRABLE AND IT IS ADVISABLE FOR THIS PURPOSE THAT THE AUTHORITIES AWARDING CONTRACTS SHOULD BE INVITED TO USE FORMS COMPLYING WITH THE PROVISIONS OF THE DIRECTIVE OR WITH THE ABOVEMENTIONED DECLARATION .  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  NOTICES OF PUBLIC WORKS CONTRACTS TO BE PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES IN CONFORMITY WITH ARTICLES 12 AND 19 OF DIRECTIVE NO 71/305/EEC SHALL NOT BE LONGER THAN ONE PAGE OF THAT JOURNAL , NAMELY ABOUT SIX HUNDRED AND FIFTY WORDS .  ARTICLE 2  ARTICLE 1 SHALL APPLY TO NOTICES RELATING TO WORKS CONCESSIONS AND SUBCONTRACTS PROVIDED FOR UNDER TITLES I AND II OF THE DECLARATION OF 26 JULY 1971 .  ARTICLE 3  THE CONTRACT NOTICES REFERRED TO IN ARTICLE 1 SHALL BE DRAWN UP ON THE BASIS OF THE HEADINGS SET OUT IN THE MODELS IN ANNEX I .  THE CONTRACT NOTICES REFERRED TO IN ARTICLE 2 AND PROVIDED FOR UNDER TITLE II OF THE DECLARATION OF 26 JULY 1971 SHALL BE DRAWN UP ON THE BASIS OF THE HEADINGS SET OUT IN THE MODEL IN ANNEX II .  EACH EDITION OF THE OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES IN WHICH ONE OR MORE CONTRACT NOTICES APPEAR SHALL REPRODUCE THE MODEL OR MODELS TO WHICH THE NOTICES PUBLISHED RELATE .  ARTICLE 4  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 26 JULY 1972 .  FOR THE COUNCIL  THE PRESIDENT  T . WESTERTERP  ANNEX I  MODEL NOTICES OF CONTRACTS  A OPEN PROCEDURES  1 . NAME AND ADDRESS OF THE AUTHORITY AWARDING THE CONTRACT ( ARTICLE 16E ) ( 1 ) :  2 . THE AWARD PROCEDURE CHOSEN ( ARTICLE 16B ) :  3 . ( A ) THE SITE ( ARTICLE 16E ) :  ( B ) THE NATURE AND EXTENT OF THE SERVICES TO BE PROVIDED AND THE GENERAL NATURE OF THE WORK ( ARTICLE 16C ) :  ( C ) IF THE CONTRACT IS SUBDIVIDED INTO SEVERAL LOTS , THE SIZE OF THE DIFFERENT LOTS AND THE POSSIBILITY OF TENDERING FOR ONE , FOR SEVERAL , OR FOR ALL OF THE LOTS ( ARTICLE 16C ) :  ( D ) INFORMATION RELATING TO THE PURPOSE OF THE CONTRACT IF THE CONTRACT ENTAILS THE DRAWING UP OF PROJECTS ( ARTICLE 16C ) :  4 . ANY TIME LIMIT FOR THE COMPLETION OF THE WORKS ( ARTICLE 16D ) :  5 . ( A ) NAME AND ADDRESS OF THE SERVICE FROM WHICH THE CONTRACT DOCUMENTS AND ADDITIONAL DOCUMENTS MAY BE REQUESTED ( ARTICLE 16F ) :  ( B ) THE FINAL DATE FOR MAKING SUCH REQUEST ( ARTICLE 16F ) :  ( C ) WHERE APPLICABLE , THE AMOUNT AND TERMS OF PAYMENT OF ANY SUM PAYABLE FOR SUCH DOCUMENTS ( ARTICLE 16F ) :  6 . ( A ) THE FINAL DATE FOR RECEIPT OF TENDERS ( ARTICLE 16G ) :  ( B ) THE ADDRESS TO WHICH THEY MUST BE SENT ( ARTICLE 16G ) :  ( C ) THE LANGUAGE OR LANGUAGES IN WHICH THEY MUST BE DRAWN UP ( ARTICLE 16G ) :  7 . ( A ) THE PERSONS AUTHORIZED TO BE PRESENT AT THE OPENING OF TENDERS ( ARTICLE 16H ) :  ( B ) THE DATE , TIME AND PLACE OF THIS OPENING ( ARTICLE 16H ) :  8 . ANY DEPOSITS AND GUARANTEES REQUIRED ( ARTICLE 16I ) :  9 . THE MAIN PROCEDURE FOR FINANCING AND PAYMENT AND/OR REFERENCES TO THE INSTRUMENTS REGULATING THESE ( ARTICLE 16J ) :  10 . WHERE APPLICABLE , THE SPECIFIC LEGAL FORM WHICH MUST BE ASSUMED BY THE GROUP OF CONTRACTORS TO WHOM THE CONTRACT IS AWARDED ( ARTICLE 16K ) ( 1 ) :  11 . THE MINIMUM ECONOMIC AND TECHNICAL STANDARDS REQUIRED OF THE CONTRACTORS ( ARTICLE 16 ) :  12 . PERIOD DURING WHICH THE TENDERER IS BOUND TO KEEP OPEN HIS TENDER ( ARTICLE 16M ) :  13 . CRITERIA FOR THE AWARD OF THE CONTRACT . CRITERIA OTHER THAN THAT OF THE LOWEST PRICE SHALL BE MENTIONED IF THEY DO NOT APPEAR IN THE CONTRACT DOCUMENTS ( ARTICLE 29 ) :  14 . OTHER INFORMATION :  15 . THE DATE OF DISPATCH OF THE NOTICE ( ARTICLE 16A ) :  B RESTRICTED PROCEDURES  1 . NAME AND ADDRESS OF THE AUTHORITY AWARDING THE CONTRACT ( ARTICLE 17A ) :  2 . THE AWARD PROCEDURE CHOSEN ( ARTICLE 17A ) :  3 . ( A ) THE SITE ( ARTICLE 17A ) :  ( B ) THE NATURE AND EXTENT OF THE SERVICES TO BE PROVIDED AND THE GENERAL NATURE OF THE WORK ( ARTICLE 17A ) :  ( C ) IF THE CONTRACT IS SUBDIVIDED INTO SEVERAL LOTS , THE SIZE OF THE DIFFERENT LOTS AND THE POSSIBILITY OF TENDERING FOR ONE , FOR SEVERAL , OR FOR ALL OF THE LOTS ( ARTICLE 17A ) :  ( D ) INFORMATION RELATING TO THE PURPOSE OF THE CONTRACT IF THE CONTRACT ENTAILS THE DRAWING UP OF PROJECTS ( ARTICLE 17A ) :  4 . ANY TIME LIMIT FOR THE COMPLETION OF THE WORKS ( ARTICLE 17A ) :  5 . WHERE APPLICABLE , THE SPECIFIC LEGAL FORM WHICH MUST BE ASSUMED BY THE GROUP OF CONTRACTORS TO WHOM THE CONTRACT IS AWARDED ( ARTICLE 17A ) :  6 . ( A ) THE FINAL DATE FOR THE RECEIPT OF REQUESTS TO PARTICIPATE ( ARTICLE 17B ) :  ( B ) THE ADDRESS TO WHICH THEY MUST BE SENT ( ARTICLE 17B ) :  ( C ) THE LANGUAGE OR LANGUAGES IN WHICH THEY MUST BE DRAWN UP ( ARTICLE 17B ) :  7 . THE FINAL DATE FOR THE DISPATCH OF INVITATIONS TO TENDER ( ARTICLE 17C ) :  8 . INFORMATION CONCERNING THE CONTRACTOR'S PERSONAL POSITION , AND THE MINIMUM ECONOMIC AND TECHNICAL STANDARDS REQUIRED OF HIM ( ARTICLE 17D ) :  9 . THE CRITERIA FOR THE AWARD OF THE CONTRACT IF THESE ARE NOT STATED IN THE INVITATION TO TENDER ( ARTICLE 18D ) :  10 . OTHER INFORMATION :  11 . THE DATE OF DISPATCH OF THE NOTICE ( ARTICLE 17A ) :  ( 1 ) THE ARTICLES IN BRACKETS REFER TO COUNCIL DIRECTIVE NO 71/305/EEC OF 26 . 7 . 1971 ( OJ NO L 185 , 16 . 8 . 1971 , P . 5 ) .  ANNEX II  MODEL NOTICE OF SUBCONTRACTS AWARDED BY THE CONCESSIONAIRE  1 . ( A ) THE SITE ( NO II ) ( 1 ) :  ( B ) THE NATURE AND EXTENT OF THE SERVICE TO BE PROVIDED AND THE GENERAL NATURE OF THE WORK ( NO II ) :  2 . ANY TIME LIMIT FOR THE COMPLETION OF THE WORKS ( NO III ) :  3 . NAME AND ADDRESS OF THE SERVICE FROM WHICH THE CONTRACT DOCUMENTS AND ADDITIONAL DOCUMENTS MAY BE REQUESTED ( NO VI ) :  4 . ( A ) THE FINAL DATE FOR RECEIPT OF TENDERS ( NO V ) :  ( B ) THE ADDRESS TO WHICH THEY MUST BE SENT ( NO VII ) :  ( C ) THE LANGUAGE OR LANGUAGES IN WHICH THEY MUST BE DRAWN UP :  5 . ANY DEPOSIT AND GUARANTEES REQUIRED ( NO IV ) :  6 . THE ECONOMIC AND TECHNICAL STANDARDS REQUIRED OF THE CONTRACTOR ( NO VIII ) :  7 . THE CRITERIA FOR THE AWARD OF THE CONTRACT ( LAST PARAGRAPH OF NO II.2 ) :  8 . OTHER INFORMATION :  9 . THE DATE OF DISPATCH OF THE NOTICE ( NO I ) :  ( 1 ) THE NUMBERS QUOTED REFER TO THE DECLARATION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES MEETING WITHIN THE COUNCIL CONCERNING PROCEDURES TO BE FOLLOWED IN THE FIELD OF PUBLIC WORKS CONCESSIONS - II SUBCONTRACTS , 2 , RULES ON PUBLICATION ( OJ NO C 82 , 16 . 8 . 1971 , P . 14 ) .


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31986L0094

Council Directive 86/94/EEC of 10 March 1986 amending for the second time Directive 73/404/EEC on the approximation of the laws of the Member States relating to detergents

Official Journal L 080 , 25/03/1986 P. 0051 - 0051 Finnish special edition: Chapter 13 Volume 15 P. 0061  Swedish special edition: Chapter 13 Volume 15 P. 0061

*****COUNCIL  DIRECTIVE  of 10 March 1986  amending for the second time Directive 73/404/EEC on the approximation of the laws of the Member States relating to detergents  (86/94/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particularr Article 100 thereof,  Having regard to the proposal from the Comission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 2a of Council Directive 73/404/EEC (4), as amended by Directive 82/242/EEC (5), provides for certain exemptions until 31 March 1986 from the requirement of a minimum biodegradability level for the non-ionic surfactants contained in detergents;  Whereas the substances in question are non-ionic surfactants which do not comply with the biodegradability limits laid down in Directive 73/404/EEC; whereas they are used for some purposes because of technical problems and in order to avoid other undesirable effects on health and the environment;  Whereas research on biodegradability of these substances has progressed since the adoption of Directive 82/242/EEC; whereas, however, the results of that research have not made it possible to dispense with all the exemption rules; whereas this derives from very wide disparities that exist between Member States as regards, inter alia, water properties, eating habits and machine design;  Whereas, although substitutes are already being used in dish-washing machine products in certain regions of the Community, no suitable substitution products have yet been found for the metal-working industry, despite intensive efforts;  Whereas, a relatively small quantity of surfactants is involved, which, however, are of considerable economic significance; whereas it is desirable to give Member States the possibility of allowing exemptions until 31 December 1989, insofar as their national situations so require,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Article 2a (1) of Directive 73/404/EEC is hereby replaced by the following:  '1. Until 31 December 1989, Member States may, exempt the following products from the requirements of the first paragraph of Article 2:  (a) low-foaming alkene oxide additives on such substances as alcohols, alkylphenols, glycols, polyols, fatty acids, amides or amines, used in dish-washing products;  (b) alkali-resistant terminally blocked alkyl and alkyl-aryl polyglycol ethers and substances of the type referred to in subparagraph (a), used in cleaning agents for the food, beverage and metal-working industries.'.  Article 1  Member States shall forthwith inform the Commission of any measures they take in order to implement this Directive.  Article 3  This Directive is addressed to Member States.  Done at Brussels, 10 March 1986.  For the Council  The President  H. van den BROEK  (1) OJ No C 139, 7. 6. 1985, p. 4.  (2) OJ No C 68, 24. 3. 1986.  (3) OJ No C 303, 25. 11. 1985, p. 26.  (4) OJ No L 347, 17. 12. 1973, p. 51.  (5) OJ No L 109, 22. 4. 1982, p. 1.


title: Commission Directive 2005/38/EC of 6 June 2005 laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium toxins in foodstuffs   (Text with EEA relevance)

text:
               7.6.2005

               EN

               Official Journal of the European Union

               L 143/18

      COMMISSION DIRECTIVE 2005/38/EC
   of 6 June 2005
   laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium toxins in foodstuffs
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1(1) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2) provides for maximum limits for certain Fusarium toxins in certain foodstuffs.

               (2)

               Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (3) lays down the general principles for the performance of control of foodstuffs. Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (4) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs.

               (3)

               Sampling plays a crucial part in the precision of the determination of the levels of Fusarium toxins, which are very heterogeneously distributed in a lot.

               (4)

               It is necessary to fix general criteria which the method of analysis should comply with in order to ensure that control laboratories use methods of analysis with comparable levels of performance.

               (5)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Member States shall ensure that sampling for the official control of the levels of Fusarium toxins (deoxynivalenol, zearalenone, fumonisins B1 and B2 and T-2 and HT-2 toxin) in foodstuffs is carried out in accordance with the methods set out in Annex I.
   Article 2
   Member States shall ensure that sample preparation and methods of analyses used for the official control of the levels of Fusarium toxins (deoxynivalenol, zearalenone, fumonisins B1 and B2 and T-2 and HT-2 toxin) in foodstuffs comply with the criteria set out in Annex II.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 6 June 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 372, 31.12.1985, p. 50. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 77, 16.3.2001, p. 1. Regulation last amended by Regulation (EC) No 856/2005 (See page 3 of this Official Journal).

      (3)  OJ L 186, 30.6.1989, p. 23.

      (4)  OJ L 290, 24.11.1993, p. 14. Directive as amended by Regulation (EC) No 1882/2003.

      ANNEX I
      METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF FUSARIUM TOXINS IN CERTAIN FOODSTUFFS
      1.   Purpose and scope
      Samples intended for official checking of the levels of Fusarium toxins content in foodstuffs shall be taken according to the methods set out in this Annex. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum limits laid down in Annex I to Regulation (EC) 466/2001 shall be established on the basis of the levels determined in the laboratory samples.
      2.   Definitions
      For the purpose of this Annex, the following definitions shall apply:
      2.1.   Lot: an identifiable quantity of a food commodity delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings.
      2.2.   Sublot: designated part of a large lot in order to apply the sampling method on that designated part; each sublot must be physically separate and identifiable.
      2.3.   Incremental sample: a quantity of material taken from a single place in the lot or sublot.
      2.4.   Aggregate sample: the combined total of all the incremental samples taken from the lot or sublot.
      3.   General provisions
      3.1.   Personnel
      Sampling shall be performed by an authorised person as designated by the Member State.
      3.2.   Material to be sampled
      Each lot which is to be examined must be sampled separately. In accordance with the point 4.3, large lots must be subdivided into sublots to be sampled separately.
      3.3.   Precautions to be taken
      In the course of sampling and preparation of the samples precautions, must be taken to avoid any changes, which would affect the Fusarium toxin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.
      3.4.   Incremental samples
      As far as possible incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from such procedure must be recorded in the record.
      3.5.   Preparation of the aggregate sample
      The aggregate sample shall be made up by uniting the incremental samples.
      3.6.   Replicate samples
      The replicate samples for enforcement, trade (defence) and reference (referee) purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with Member States’ rules.
      3.7.   Packaging and transmission of samples
      Each sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage.
      3.8.   Sealing and labelling of samples
      Each sample taken for official use shall be sealed at the place of sampling and identified following the regulations of the Member State.
      A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.
      4.   Specific provisions
      4.1.   Different types of lots
      Food commodities may be traded in bulk, containers, or individual packings, such as sacks, bags, retail packings. The sampling procedure may be applied to all the different forms in which the commodities are put on the market.
      Without prejudice to the specific provisions set out in points 4.3, 4.4 and 4.5, the following formula may be used as a guide for the sampling of lots traded in individual packs, such as sacks, bags, retail packings.

                  —

                  weight: in kg

                  —

                  sampling frequency (SF): every nth sack or bag from which an incremental sample must be taken (decimal figures should be rounded to the nearest whole number).

            4.2.   Weight of the incremental sample
      The weight of the incremental sample must be about 100 grams, unless otherwise defined in this Annex. In the case of lots in retail packings, the weight of the incremental sample shall depend on the weight of the retail packing.
      4.3.   General survey of the sampling procedure for cereals and cereal products
      Table 1
      Subdivision of lots into sublots depending on product and lot weight

                  Commodity

                  Lot weight
                  (tonnes)

                  Weight or number of sublots

                  No incremental samples

                  Aggregate sample Weight
                  (kg)

                  Cereals and cereal products

                  ≥ 1 500

                  500 tonnes

                  100

                  10

                  > 300 and < 1 500

                  3 sublots

                  100

                  10

                  ≥ 50 and ≤ 300

                  100 tonnes

                  100

                  10

                  < 50

                  —

                  3-100 (1)

                  1-10

            4.4.   Sampling procedure for cereals and cereal products for lots ≥ 50 tonnes

                  —

                  On condition that the sublot can be separated physically, each lot must be subdivided into sublots following Table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

                  —

                  Each sublot must be sampled separately.

                  —

                  Number of incremental samples: 100. Weight of the aggregate sample = 10 kg.

                  —

                  If it is not possible to carry out the method of sampling set out in this point because of the commercial consequences resulting from damage to the lot such as packaging forms, means of transport, an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

            4.5.   Sampling procedure for cereals and cereal products for lots < 50 tonnes
      For lots of cereals and cereal products less than 50 tonnes, the sampling plan must be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at least 1 kg.
      The figures in Table 2 may be used to determine the number of incremental samples to be taken.
      Table 2
      Number of incremental samples to be taken depending on the weight of the lot of cereals and cereal products

                  Lot weight (tonnes)

                  No of incremental samples

                  ≤ 0,05

                  3

                  > 0,05-≤ 0,5

                  5

                  > 0,5-≤ 1

                  10

                  > 1-≤ 3

                  20

                  > 3-≤ 10

                  40

                  > 10-≤ 20

                  60

                  > 20-≤ 50

                  100

            4.6.   Sampling procedure for foods intended for infants and young children

                  —

                  The sampling procedure for cereals and cereal products as set out in point 4.5 shall apply to food intended for infants and young children. Accordingly the number of incremental samples to be taken shall depend on the weight of the lot, with a minimum of 10 and a maximum of 100, in accordance with Table 2 at point 4.5. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at least 1 kg.

                  —

                  Weight of the incremental sample must be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample shall depend on the weight of the retail packing and in case of very small lots (≤ 0,5 tonnes) the incremental samples must have a weight as such that uniting the incremental samples results in an aggregate sample of at least 1 kg.

                  —

                  Weight of aggregate sampling = 1-10 kg sufficiently mixed.

            4.7.   Sampling at retail stage
      Sampling of foodstuffs at the retail stage must be done where possible in accordance with the sampling provisions set out in points 4.4. and 4.5. Where that is not possible, other effective sampling procedures at retail stage may be used provided that they ensure sufficient representativeness for the sampled lot.
      5.   Acceptance of a lot or sublot

                  —

                  Acceptance if the aggregate sample conforms to the maximum limit, taking into account the measurement uncertainty and correction for recovery.

                  —

                  Rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into account the measurement uncertainty and correction for recovery.

         (1)  Depending on the lot weight — see Table 2.

      ANNEX II
      SAMPLE PREPARATION AND CRITERIA FOR METHODS OF ANALYSIS USED IN OFFICIAL CHECKING OF THE LEVELS OF FUSARIUM TOXINS IN CERTAIN FOODSTUFFS
      1.   Precautions
      As the distribution of Fusarium toxins is non-homogeneous, samples shall be prepared, and especially homogenised, with extreme care.
      All the material received by the laboratory must be used for the preparation of test material.
      2.   Treatment of the sample as received in the laboratory
      Each laboratory sample must be finely grinded and mixed thoroughly using a process that has been demonstrated to achieve complete homogenisation.
      In case the maximum level applies to the dry matter, the dry matter content of the product shall be determined on a part of the homogenised sample, using a procedure that has been demonstrated to determine accurately the dry matter content.
      3.   Subdivision of samples for enforcement and defence purposes
      The replicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised material unless such procedure conflicts with Member States’ rules on sampling.
      4.   Method of analysis to be used by the laboratory and laboratory control requirements
      4.1.   Definitions
      A number of the most commonly used definitions that the laboratory shall be required to use are the following:
      The most commonly quoted precision parameters are repeatability and reproducibility.

                  r

                  =

                  Repeatability, the value below which the absolute difference between two single test results obtained under repeatability conditions, namely same sample, same operator, same apparatus, same laboratory, and short interval of time may be expected to lie within a specific probability (typically 95 %) and hence r = 2,8 × sr

                  sr

                  =

                  Standard deviation, calculated from results generated under repeatability conditions

                  RSDr

                  =

                  Relative standard deviation, calculated from results generated under repeatability conditions

                  R

                  =

                  Reproducibility, the value below which the absolute difference between single test results obtained under reproducibility conditions, namely on identical material obtained by operators in different laboratories, using the standardised test method may be expected to lie within a certain probability (typically 95 %); R = 2,8 × sR

                  sR

                  =

                  Standard deviation, calculated from results under reproducibility conditions

                  RSDR

                  =

                  Relative standard deviation calculated from results generated under reproducibility conditions .

            4.2.   General requirements
      Methods of analysis used for food control purposes must comply with the provisions of items 1 and 2 of the Annex to Directive 85/591/EEC.
      4.3.   Specific requirements
      4.3.1.   Performance Criteria
      Where no specific methods for the determination of Fusarium toxins levels in foodstuffs are required by Community legislation, laboratories may select any method provided the selected method meets the following criteria:

                  (a)

                  Performance characteristics for deoxynivalenol

                              Level μg/kg

                              Deoxynivalenol

                              RSDr %

                              RSDR %

                              Recovery %

                              > 100-≤ 500

                              ≤ 20

                              ≤ 40

                              60 to 110

                              > 500

                              ≤ 20

                              ≤ 40

                              70 to 120

                  (b)

                  Performance characteristics for zearalenone

                              Level μg/kg

                              Zearalenone

                              RSDr %

                              RSDR %

                              Recovery %

                              ≤ 50

                              ≤ 40

                              ≤ 50

                              60 to 120

                              > 50

                              ≤ 25

                              ≤ 40

                              70 to 120

                  (c)

                  Performance characteristics for Fumonisin B1 and B2

                              Level μg/kg

                              Fumonisin B1 or B2

                              RSDr %

                              RSDR %

                              Recovery %

                              ≤ 500

                              ≤ 30

                              ≤ 60

                              60 to 120

                              > 500

                              ≤ 20

                              ≤ 30

                              70 to 110

                  (d)

                  Performance characteristics for T-2 and HT-2 toxin

                              Level μg/kg

                              T-2 toxin

                              RSDr %

                              RSDR %

                              Recovery %

                              50-250

                              ≤ 40

                              ≤ 60

                              60 to 130

                              > 250

                              ≤ 30

                              ≤ 50

                              60 to 130

                              Level μg/kg

                              HT-2 toxin

                              RSDr %

                              RSDR %

                              Recovery %

                              100-200

                              ≤ 40

                              ≤ 60

                              60 to 130

                              > 200

                              ≤ 30

                              ≤ 50

                              60 to 130

            The detection limits of the methods used are not stated as the precision values are given at the concentrations of interest.
      The precision values are calculated from the Horwitz equation:

                  RSDR = 2(1-0,5logC)

            where:

                  RSDR is the relative standard deviation calculated from results generated under reproducibility conditions

                  C is the concentration ratio (i.e. 1 = 100 g/100 g, 0,001 = 1 000 mg/kg

            That is a generalised precision equation, which has been found to be independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.
      4.3.2.   ‘Fitness-for-purpose’ approach
      In the case where there are a limited number of fully validated methods of analysis, alternatively, a ‘fitness-for-purpose’ approach, defining a single parameter, a fitness function, to evaluate the acceptability of methods of analysis may be used. A fitness function is an uncertainty function that specifies maximum levels of uncertainty regarded as fit for purpose.
      Given the limited number of methods of analysis, fully validated by a collaborative trial, especially for the determination of T-2 and HT-2 toxin, the uncertainty function approach, specifying the maximum acceptable uncertainty, may also be used to assess the suitability (the ‘fitness-for-purpose’) of the method of analysis to be used by the laboratory. The laboratory may use a method which produces results within the maximum standard uncertainty. The maximum standard uncertainty may be calculated using the following formula:

      where:

                  —

                     Uf is the maximum standard uncertainty (μg/kg)

                  —

                  LOD is the limit of detection of the method (μg/kg)

                  —

                  α is a constant, numeric factor to be used depending on the value of C. The values to be used are set out in Table 3

                  —

                  C is the concentration of interest (μg/kg).

            If the analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method shall be considered being equally suitable to one which meets the performance characteristics given in point 4.3.1.
      Table 3
      Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest

                  C (μg/kg)

                  α

                  ≤ 50

                  0,2

                  51-500

                  0,18

                  501-1 000

                  0,15

                  1 001-10 000

                  0,12

                  > 10 000

                  0,1

            4.4.   Recovery calculation and reporting of results
      The analytical result must be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported. The analytical result corrected for recovery shall be used for checking compliance (see Annex I, point 5).
      The analytical result must be reported as x +/– U whereby x is the analytical result and U is the expanded measurement uncertainty.
      U is the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.
      4.5.   Laboratory quality standards
      Laboratories must comply with Council Directive 93/99/EEC.