title: Commission Directive 2006/60/CE of  7 July 2006  amending Annexes to Council Directive 90/642/EEC as regards the maximum residue levels of trifloxystrobin, thiabendazole, abamectin, benomyl, carbendazim, thiophanate-methyl, myclobutanyl, glyphosate, trimethylsulfonium, fenpropimorph and chlormequat   (Text with EEA relevance)

text:
               27.7.2006

               EN

               Official Journal of the European Union

               L 206/1

      COMMISSION DIRECTIVE 2006/60/CE

   of 7 July 2006
   amending Annexes to Council Directive 90/642/EEC as regards the maximum residue levels of trifloxystrobin, thiabendazole, abamectin, benomyl, carbendazim, thiophanate-methyl, myclobutanyl, glyphosate, trimethylsulfonium, fenpropimorph and chlormequat
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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 (1), 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 (2), 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 Directive 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 will lead to changes in the residue levels of trifloxystrobin, thiabendazole, abamectin, the benomyl group (benomyl, carbendazim, and thiophanate-methyl), myclobutanyl, glyphosate, trimethylsulfonium and fenpropimorph.

               (4)

               For chlormequat information has been communicated to the Commission that justifies the adoption of a temporary MRL on pears for three years.

               (5)

               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 Organization (3). In this evaluation it was taken into account that abamectin and thiabendazole are also used as veterinary medicines intended for food producing animals and that Maximum Residues Limits have been establishment for those two substances in accordance with the provisions of Council Regulation (EEC) No 2377/90 (4). Based on that assessment and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded.

               (6)

               In the case of benomyl, carbendazim, thiophanate-methyl, fenpropimorph and chlormequat 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 Organization. The opinions of the Scientific Committee on Plants, 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.

               (7)

               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.

               (8)

               Therefore it is appropriate to fix new MRLs for those pesticides.

               (9)

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

               (10)

               Lupines are consumed as food in several Member States. On lupines the use of glyphosate is authorised. The insertion of the entry ‘lupines’ and setting of MRLs for lupines is therefore necessary to protect consumers from excess pesticide residues used on lupines.

               (11)

               Directive 90/642/EEC should therefore be amended accordingly.

               (12)

               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 90/642/EEC is amended as follows:

               1.

               in Annex I, in group ‘3 Pulses’, the entry ‘Lupines’ is added in such a way that the terms ‘Whole product’ in the last column cover all four entries;

               2.

               Annex II is amended in accordance with the Annex to this Directive.

         Article 2
   1.   Member States shall adopt and publish, by 20 January 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive, except for the benomyl group and thiophanate-methyl for which they shall adopt and publish these by fourteen September 2006 and for chlormequat by thirty one July 2006. 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 21 January 2007, except for the benomyl group and thiophanate-methyl for which they shall be applied by fifteen September 2006 and for chlormequat by the first of August 2006.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 7 July 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/53/EC (OJ L 154, 8.6.2006, p. 11).

      (2)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).

      (3)  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).

      (4)  OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC No 205/2006 (OJ L 34, 7.2.2006, p. 21).

      (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, 14 July 1998); Opinion regarding variable pesticide residues in fruit and vegetables (Opinion expressed by SCP on 14 July 1998) http://europa.eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html

      ANNEX
      Annex II to Directive 90/642/EEC is amended as follows:

                  1.

                  the footnote (t) at the entry for chlormequat on pears is replaced by the following: ‘A temporary MRL of 0,2 mg/kg shall apply until 31 July 2009’;

                  2.

                  in part A, the columns for trifloxystrobin, thiabendazole, abamectin, benomyl, carbendazim, thiophanate-methyl, myclobutanyl, glyphosate, trimethylsulfonium and fenpropimorph are replaced by the following:

                              Pesticide residue and maximum residue level (mg/kg)

                              Groups and examples of individual products to which the MRLs would apply

                              Trifloxy-strobin

                              Thiaben-dazole

                              Abamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a)

                              Sum of benomyl and carbendazim, expressed as carbendazim

                              Thiophanate-methyl

                              Myclobutanyl

                              Glyphosate

                              Trimethyl-sulfonium, cation resulting from the use of glyphosate

                              Fenpropi-morph

                              ‘1.

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

                              (i)

                              CITRUS FRUIT

                              0,3 (2)

                              5

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              3

                              0,05 (1)

                              Grapefruit

                              Lemons

                              Limes

                              Mandarins (including clementines and other hybrids)

                              0,5 (2)

                              0,5 (2)

                              Oranges

                              0,5 (2)

                              0,5 (2)

                              Pomelos

                              Others

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              (ii)

                              TREE NUTS (shelled or unshelled)

                              0,02 (1)
                                  (2)

                              0,1 (1)

                              0,02 (1)

                              0,1 (1)

                              0,2

                              0,05 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Almonds

                              Brazil nuts

                              Cashew nuts

                              Chestnuts

                              Coconuts

                              Hazelnuts

                              Macadamia

                              Pecans

                              Pine nuts

                              Pistachios

                              Walnuts

                              Others

                              (iii)

                              POME FRUIT

                              0,5 (2)

                              0,01 (1)

                              0,2

                              0,5

                              0,5

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Apples

                              5

                              Pears

                              5

                              Quinces

                              Others

                              0,05 (1)

                              (iv)

                              STONE FRUIT

                              0,05 (1)

                              0,01 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Apricots

                              1 (2)

                              0,2

                              2

                              0,3

                              Cherries

                              1 (2)

                              0,5

                              0,3

                              1

                              Peaches (including nectarines and similar hybrids)

                              1 (2)

                              0,2

                              2

                              0,5

                              Plums

                              0,2 (2)

                              0,5

                              0,3

                              0,5

                              Others

                              0,02 (1)
                                  (2)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              (v)

                              BERRIES AND SMALL FRUITAND

                              0,05 (1)

                              0,05 (1)
                                  (2)

                              (a)

                              Table and wine grapes

                              5 (2)

                              0,01 (1)

                              1

                              0,5 (2)

                              0,05 (1)

                              Table grapes

                              0,3

                              0,1 (1)

                              Wine grapes

                              0,5

                              3

                              (b)

                              Strawberries (other than wild)

                              0,5 (1)
                                  (2)

                              0,1

                              0,1 (1)

                              0,1 (1)

                              1

                              0,1 (1)
                                  (2)

                              1

                              (c)

                              Cane fruit (other than wild)

                              0,02 (1)
                                  (2)

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              1

                              Blackberries

                              0,1

                              1

                              Dewberries

                              Loganberries

                              Raspberries

                              0,1

                              1

                              Others

                              0,01 (1)

                              0,02 (1)

                              (d)

                              Other small fruit and berries (other than wild)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              1

                              Bilberries

                              Cranberries

                              Currants (red, black and white)

                              1 (2)

                              1

                              Gooseberries

                              1 (2)

                              1

                              Others

                              0,02 (1)
                                  (2)

                              0,02 (1)

                              (e)

                              Wild berries and wild fruit

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)

                              (vi)

                              MISCELLANEOUS

                              0,01 (1)

                              Avocados

                              15

                              Bananas

                              0,05 (2)

                              5

                              2

                              2

                              Dates

                              Figs

                              Kiwi

                              Kumquats

                              Litchis

                              Mangoes

                              5

                              Olives (table consumption)

                              Olives (oil extraction)

                              1 (2)

                              1 (2)

                              Papaya

                              10

                              0,2

                              1

                              Passion fruit

                              Pineapples

                              Pomegranate

                              Others

                              0,02 (1)
                                  (2)

                              0,05 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              2.

                                 Vegetables, fresh or uncooked, frozen or dry

                              (i)

                              ROOT AND TUBER VEGETABLES

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Beetroot

                              Carrots

                              0,2

                              Cassava

                              15

                              Celeriac

                              Horseradish

                              0,2

                              Jerusalem artichokes

                              Parsnips

                              0,2

                              Parsley root

                              0,2

                              Radishes

                              Falsify

                              Sweet potatoes

                              15

                              Swedes

                              Turnips

                              Yam

                              15

                              Others

                              0,05 (1)

                              0,02 (1)

                              (ii)

                              BULB VEGETABLES

                              0,02 (1)
                                  (2)

                              0,05 (1)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Garlic

                              Onions

                              Shallots

                              Spring onions

                              Others

                              (iii)

                              FRUITION VEGETABLES

                              0,05 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              (a)

                              Solanacea

                              Tomatoes

                              0,5 (2)

                              0,02

                              0,5

                              2

                              0,3

                              Peppers

                              0,05

                              0,5

                              Aubergines

                              0,02

                              0,5

                              2

                              0,3

                              Okra

                              2

                              1

                              Others

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              (b)

                              Cucurbits - edible peel

                              0,2 (2)

                              0,02

                              0,1 (1)

                              0,1 (1)

                              0,1

                              Cucumbers

                              Gherkins

                              Courgettes

                              Others

                              (c)

                              Cucurbits - inedible peel

                              0,01 (1)

                              0,1 (1)

                              0,3

                              0,2

                              Melons

                              0,3 (2)

                              Squashes

                              Watermelons

                              Others

                              0,02 (1)
                                  (2)

                              (d)

                              Sweet corn

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              (iv)

                              BRASSICA VEGETABLES

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,02 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              (a)

                              Flowering brassica

                              0,1 (1)

                              0,1 (1)

                              0,05 (1)

                              Broccoli (including Calabrese)

                              5

                              Cauliflower

                              Others

                              0,05 (1)

                              (b)

                              Head brassica

                              0,05 (1)

                              Brussels sprouts

                              0,5

                              1

                              0,5

                              Head cabbage

                              Others

                              0,1 (1)

                              0,1 (1)

                              0,05 (1)

                              (c)

                              Leafy brassica

                              0,05 (1)

                              0,1 (1)

                              0,1 (1)

                              0,05 (1)

                              Chinese cabbage

                              Kale

                              Others

                              (d)

                              Kohlrabi

                              0,05 (1)

                              0,1 (1)

                              0,1 (1)

                              0,05 (1)

                              (v)

                              LEAF VEGETABLES AND FRESH HERBSAND

                              0,02 (1)
                                  (2)

                              0,05 (1)

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              (a)

                              Lettuce and similar

                              0,1

                              Cress

                              Lamb's lettuce

                              5

                              Lettuce

                              Scarole (broad-leaf endive)

                              Ruccola

                              Leaves and stems of brassica

                              Others

                              0,02 (1)

                              (b)

                              Spinach and similar

                              0,01 (1)

                              0,02 (1)

                              Spinach

                              Beet leaves (chard)

                              Others

                              (c)

                              Water cress

                              0,01 (1)

                              0,02 (1)

                              (d)

                              Witloof

                              1

                              0,01 (1)

                              0,02 (1)

                              (e)

                              Herbs

                              0,01 (1)

                              0,02 (1)

                              Chervil

                              Chives

                              Parsley

                              Celery leaves

                              Others

                              (vi)

                              LEGUME VEGETABLES (fresh)

                              0,05 (1)

                              0,01 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Beans (with pods)

                              0,5 (2)

                              0,2

                              0,1 (1)

                              0,3

                              Beans (without pods)

                              Peas (with pods)

                              0,2

                              0,1 (1)

                              Peas (without pods)

                              Others

                              0,02 (1)
                                  (2)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              (vii)

                              STEM VEGETABLES (fresh)

                              0,02 (1)
                                  (2)

                              0,05 (1)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              Asparagus

                              Cardoons

                              Celery

                              Fennel

                              Globe artichokes

                              0,5

                              Leek

                              1

                              Rhubarb

                              Others

                              0,02 (1)

                              0,05 (1)

                              (viii)

                              FUNGI

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,05 (1)

                              (a)

                              Cultivated mushrooms

                              10

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              (b)

                              Wild mushrooms

                              0,05 (1)

                              50 (2)

                              20 (2)

                              3.

                                 Pulses

                              0,02 (1)
                                  (2)

                              0,05 (1)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Beans

                              2 (2)

                              Lentils

                              Peas

                              10 (2)

                              Lupins

                              10 (2)

                              Others

                              0,1 (1)
                                  (2)

                              4.

                                 Oilseeds

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              0,02 (1)

                              0,05 (1)

                              0,05 (1)

                              Linseed

                              10 (2)

                              Peanuts

                              Poppy seed

                              Sesame seed

                              Sunflower seed

                              20 (2)

                              Rape seed

                              10 (2)

                              Soya bean

                              0,2

                              0,3

                              20 (2)

                              10 (2)

                              Mustard seed

                              10 (2)

                              Cotton seed

                              10 (2)

                              Hemp seed

                              Others

                              0,1 (1)

                              0,1 (1)

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              5.

                                 Potatoes

                              0,02 (1)
                                  (2)

                              0,01 (1)

                              0,1 (1)

                              0,1 (1)

                              0,02 (1)

                              0,5 (2)

                              0,05 (1)
                                  (2)

                              0,05 (1)

                              Early potatoes

                              0,05 (1)

                              Ware potatoes

                              15

                              6.

                                 Tea (dried leaves and stalks, fermented or other-wise, Camellia sinensis)

                              0,05 (1)
                                  (2)

                              0,1 (1)

                              0,02 (1)

                              0,1 (1)

                              0,1 (1)

                              0,05 (1)

                              2 (2)

                              0,05 (1)
                                  (2)

                              0,1 (1)

                              7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                              30 (2)

                              0,1 (1)

                              0,05

                              0,1 (1)

                              0,1 (1)

                              2

                              0,1 (1)
                                  (2)

                              0,05 (1)
                                  (2)

                              10

         (1)  Indicates lower limit of analytical determination.

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


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Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of environments concerned by waste from the titanium dioxide industry

Official Journal L 378 , 31/12/1982 P. 0001 - 0014 Finnish special edition: Chapter 15 Volume 4 P. 0042  Spanish special edition: Chapter 15 Volume 4 P. 0003  Swedish special edition: Chapter 15 Volume 4 P. 0042  Portuguese special edition Chapter 15 Volume 4 P. 0003

COUNCIL DIRECTIVE of 3 December 1982 on procedures for the surveillance and monitoring of environments concerned by waste from the titanium dioxide industry (82/883/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof,  Having regard to Council Directive 78/176/EEC of 20 February 1978 on waste from the titanium dioxide industry (1), and in particular Article 7 (3) thereof,  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas, irrespective of the method and extent of the treatment of wastes from the titanium dioxide industry, the discharge, dumping, storage on, tipping on or injection into the ground of such wastes must be accompanied by measures for the surveillance and monitoring of the environments concerned from a physical, chemical, biological and ecological point of view;  Whereas, in order to monitor the quality of these environments, samples should be taken with a minimum frequency so that the parameters specified in the Annexes may be measured ; whereas the number of these sampling operations could be reduced in the light of the results obtained ; whereas, to ensure that the monitoring is effective, samples should also be taken if possible in a zone deemed to be unaffected by the discharges in question;  Whereas, in connection with the analyses carried out by the Member States, common reference methods of measurement should be fixed for determining the parametric values which define the physical, chemical, biological and ecological characteristics of the environments concerned;  Whereas, for the surveillance and monitoring of the environments affected, Member States may at any time lay down other parameters in addition to those laid down by this Directive;  Whereas it is necessary to define the details of the methods of surveillance and monitoring which Member States communicate to the Commission ; whereas the Commission shall, with the prior agreement of the Member States, publish a consolidated report on these details;  Whereas in certain natural circumstances it may prove difficult to carry out the surveillance and monitoring operations, and, accordingly, provision must be made for derogation, in certain cases, from this Directive;  Whereas technical and scientific progress may require the rapid adjustment of certain of the provisions contained in the Annex ; whereas to facilitate implementation of the requisite measures a procedure should be laid down to establish close (1) OJ No L 54, 25.2.1978, p. 19. (2) OJ No C 356, 31.12.1980, p. 32 and OJ No C 187, 22.7.1982, p. 10. (3) OJ No C 149, 14.6.1982, p. 101. (4) OJ No C 230, 10.9.1981, p. 5.    cooperation between the Member States and the Commission through a committee on adaptation to scientific and technical progress,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive lays down, pursuant to Article 7 (3) of Directive 78/176/EEC, the procedures for the surveillance and monitoring of the effects on the environment, having regard to its physical, chemical, biological and ecological aspects, of the discharge, dumping, storage on, tipping on or injection into the ground of waste from the titanium dioxide industry.   Article 2 For the purpose of this Directive:    - "environments affected" means the water, the land surface and underground strata and the air in or into which waste from the titanium dioxide industry is discharged, dumped, stored, tipped or injected,       - "sampling point" means the point at which samples are taken.          Article 3 1. The parameters applicable for the surveillance and monitoring referred to in Article 1 are specified in the Annexes.  2. Where a parameter appears in the "mandatory determination" column in the Annexes, sampling and analysis of the samples must be carried out in respect of the environmental components indicated.  3. Where a parameter appears in the "optional determination" column in the Annexes, the Member States shall, if they consider it necessary, have the sampling and analysis of samples carried out for the environmental components indicated.   Article 4 1. Member States shall carry out surveillance and monitoring of the environments affected and of a neighbouring zone deemed to be unaffected, special account being taken of local environmental factors and the manner of disposal, i.e. whether intermittent or continuous.  2. Except where otherwise specified in the Annexes, Member States shall determine on a case-by-case basis the exact sites from which samples are to be taken, the distance of these sites from the nearest pollutant disposal point and the depth or height at which the samples must be taken.  The samples must be taken at the same location and depth and under the same conditions in the course of successive sampling operations, for example in the case of tidal waters, at the same time in relation to high tide, tidal coefficient.  3. For the monitoring and inspection of the environments affected, Member States shall determine the frequency of sampling and analysis for each parameter listed in the Annexes.  For parameters where determination is mandatory, the frequency of sampling and analysis must not be less than the minimum frequencies indicated in the Annexes. However, once the behaviour, fate and effects of the waste have, as far as possible, been established, and provided there is no significant deterioration in the quality of the environment, Member States may provide for a frequency of sampling and analysis below these frequencies. Should there subsequently be any significant deterioration in the quality of the environment as a result of the waste or of any change in the disposal operation, the Member State shall revert to sampling and analysis at a frequency not less than that specified in the Annexes. If a Member State considers it necessary or advisable, it may distinguish between different parameters, applying this subparagraph to those parameters where no significant deterioration in the quality of the environment has been recorded.  4. For the monitoring and inspection of an appropriate neighbouring zone deemed to be unaffected, the laying down of the frequency of sampling and analysis shall be assessed by the Member States. When a Member State finds that it is not possible to identify such a neighbouring zone, it shall inform the Commission to that effect.   Article 5 1. The reference methods of measurement for determining the parametric values are specified in the Annexes. Laboratories using other methods must ensure that the results obtained are comparable.  2. The containers used to carry the samples, the agents or methods used to preserve a part sample  with a view to analysis of one or more parameters, the transport and storage of samples and their preparation for analysis must be such that they do not significantly affect the analytical results.   Article 6 For the surveillance and monitoring of the environments affected, Member States may, at any time, lay down other parameters in addition to those laid down by this Directive.   Article 7 1. The report which the Member States are required to forward to the Commission pursuant to Article 14 of Directive 78/176/EEC shall contain details of the surveillance and monitoring operations carried out by the bodies appointed in accordance with Article 7 (2) of that Directive. These details shall, in respect of each environment affected, include the following information:    - a description of the sampling point, including its permanent features, which may be coded, and other administrative and geographical information. This information shall be provided only once when the sampling point is designated,       - a description of the sampling methods used,       - the results of the measurements of the parameters whose determination is mandatory and, where Member States consider it useful, also those of parameters whose determination is optional,       - the methods of measurement and analysis used and, where appropriate, their limit of detection, accuracy and precision,       - changes, adopted in accordance with Article 4 (3), in the frequency of sampling and analysis.         2. The first set of data to be communicated pursuant to paragraph 1 shall be that gathered during the third year following notification of this Directive.  3. The Commission shall, with the prior agreement of the Member State concerned, publish a summary of the information supplied to it.  4. The Commission shall assess the effectiveness of the procedure for the surveillance and monitoring of the environments affected and shall - no later than six years after notification of this Directive - place before the Council, if appropriate, proposals to improve this procedure and, if necessary, to harmonize the methods of measurement including their limit of detection, accuracy and precision and the sampling methods.   Article 8 Member States may derogate from this Directive in the event of flooding or natural disaster or on account of exceptional weather conditions.   Article 9 The requisite amendments to adapt the contents of the Annexes as regards:    - parameters listed in the "optional determination" column,       - reference methods of measurement,         to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 11.   Article 10 1. A committee on adaptation to technical progress (hereinafter referred to as "the committee"), consisting of representatives of the Member States and chaired by a Commission representative, is hereby set up.  2. The committee shall draw up its rules of procedure.   Article 11 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the committee by its chairman, either on his own initiative or at the request of the representative of a Member State.  2. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall give its opinion on the draft within a time limit set by the chairman having regard to the urgency of the matter. Opinions shall be delivered by a majority of 45 votes, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.  3.   (a)  Where the measures envisaged are in accordance with the opinion of the committee, the Commission shall adopt them.    (b)  Where the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal on the measues to be taken. The Council shall act by a qualified majority.   (c)  If the Council has not acted within three months of the proposals being submitted to it, the proposed measures shall be adopted by the Commission.   Article 12 Point (c) of Article 8 (1) of Directive 78/176/EEC is hereby replaced by the following:  "(c) if the results of the monitoring which the Member States are obliged to carry out on the environment concerned reveal a deterioration in the area under consideration, or".   Article 13 Where waste elimination requires that, in accordance with Article 4 (1) of Directive 78/176/EEC, the competent authorities of more than one Member State should issue prior authorizations, the Member States involved shall consult each other on the content and the implementation of the monitoring programme.   Article 14 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years following its notification. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.   Article 15 This Directive is addressed to the Member States.     Done at Brussels, 3 December 1982.  For the Council  The President  Ch. CHRISTENSEN     ANNEX I METHOD OF WASTE DISPOSAL : DISCHARGE INTO AIR  >PIC FILE= "T0022415">     ANNEX II METHOD OF WASTE DISPOSAL : DISCHARGE INTO OR IMMERSION IN SALT WATER (estuarine, coastal, open sea)  >PIC FILE= "T0022416">    >PIC FILE= "T0022417">    >PIC FILE= "T0022418">     ANNEX III METHOD OF WASTE DISPOSAL : DISCHARGE INTO FRESH SURFACE WATER  >PIC FILE= "T0022419">    >PIC FILE= "T0022420">    >PIC FILE= "T0022421">    >PIC FILE= "T0022422">     ANNEX IV METHOD OF WASTE DISPOSAL : STORAGE AND DUMPING ON LAND  >PIC FILE= "T0022423">     ANNEX V METHOD OF WASTE DISPOSAL : INJECTION INTO SOIL >PIC FILE= "T0022424">


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31983L0265

Council Directive 83/265/EEC of 16 May 1983 amending Directive 77/728/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products

Official Journal L 147 , 06/06/1983 P. 0011 - 0017 Finnish special edition: Chapter 13 Volume 12 P. 0185  Spanish special edition: Chapter 13 Volume 14 P. 0065  Swedish special edition: Chapter 13 Volume 12 P. 0185  Portuguese special edition Chapter 13 Volume 14 P. 0065

COUNCIL DIRECTIVE of 16 May 1983 amending Directive 77/728/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products (83/265/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 it has been considered desirable that the rules embodied in the separate Directives on preparations and in particular in Directives 73/173/EEC (4), as last amended by Directive 80/781/EEC (5), and 77/728/EEC (6) should be replaced by a single Directive concerning all preparations ; whereas it is not yet possible to adopt such a Directive ; whereas it is necessary in the meantime to amend Directive 77/728/EEC;  Whereas paints, varnishes, printing inks and adhesives subject to the provisions of Directive 77/728/EEC frequently contain solvents covered by the provisions of Directive 73/173/EEC ; whereas, during the transposition of these two Directives into national law, difficulties have appeared in several Member States because different terms describing the same thing have been used in both texts ; whereas it is, therefore, necessary to harmonize the text and scope of both Directives as far as possible;  Whereas, in different Articles of Directives 77/728/EEC, account should be taken of the amendments made to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (7) by Directive 79/831/EEC (8), particularly the newly introduced danger categories "very toxic" and "extremely flammable";  Whereas Article 3 of Directive 77/728/EEC contains provisions for classification of the preparations according to the degree of risk ; whereas, for the classification of the preparations as toxic or harmful, reference is made inter alia to Directive 73/173/EEC ; whereas, since the original version of Directive 73/173/EEC made no reference to corrosive and irritant solvents, it was unable to provide any details concerning these categories;  Whereas, now that the scope of Directive 73/173/EEC has been extended to cover corrosive and irritant solvents, Article 3 (3) (c) and (d) of Directive 77/728/EEC should be amended accordingly;  Whereas the wording of the third indent of Article 3 (3) (a) of Directive 77/728/EEC has proved difficult to interpret and should, therefore, be drafted more precisely and supplemented ; whereas, for the same reason, additions should be made to the last indent of Article 3 (3) (b), (c) and (d), respectively, of that Directive,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Articles 1 to 11 of Directive 77/728/EEC shall be replaced by the following text:  "Article 1  1. This Directive shall concern:    - the classification,       - the packaging,       - the labelling,  (1) OJ No C 156, 25.6.1981, p. 8. (2) OJ No C 125, 17.5.1982, p. 148. (3) OJ No C 310, 30.11.1981, p. 31. (4) OJ No L 189, 11.7.1973, p. 7. (5) OJ No L 229, 30.8.1980, p. 57. (6) OJ No L 303, 28.11.1977, p. 23. (7) OJ No 196, 16.8.1967, p. 1. (8) OJ No L 259, 15.10.1979, p. 10.   of preparations intended to be used as:       - paints, varnishes, printing inks, coatings, adhesives, jointing compounds, putties, sealants, undercoats, paint strippers, degreasing agents, artists' colours or release agents,       - preservatives and primers not covered by other Community regulations,        and of dangerous preparations used in the manufacture of the aforesaid products.  2. This Directive shall apply to the preparations listed in paragraph 1 which are placed on the market in the Member States and are classified as dangerous under both Article 2 (2) of Directive 67/548/EEC and Article 3 of this Directive.  3. This Directive shall also apply to the preparations listed in Annex II hereto.  4. The definitions specified in Article 2 of Directive 67/548/EEC shall apply to this Directive, with the exception of those in (1) (c) and (d) and in (2) (k).  Article 2 1. This Directive shall not apply to:    (a) the carriage of dangerous preparations by rail, road, inland waterway, sea or air;       (b) preparations for export to third countries;       (c) preparations in transit subject to customs supervision, provided that they are not altered or treated in any way;       (d) cosmetic preparations coming under Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1);       (e) additives for foodstuffs and animal feed, fertilizers and pesticides where Community Directives on the classification, packaging and labelling of such preparations are in force, except where the Directives in question refer specifically to this Directive;       (f) substances which are in the form of waste and which are covered by Council Directive 75/442/EEC of 15 July 1975 on waste (2) and Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (3).         2. Articles 5 to 7 of this Directive shall not apply to containers for gaseous preparations which are compressed, liquefied or disolved under pressure, with the exception of aerosols as defined in Article 2 of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (4).  (1) OJ No L 262, 27.9.1976, p. 169. (2) OJ No L 194, 25.7.1975, p. 39. (3) OJ No L 84, 31.3.1978, p. 43. (4) OJ No L 147, 9.6.1975, p. 40.    Article 3 1. In preparations covered by this Directive, concentrations of the dangerous substances listed in Annex I to Directive 67/548/EEC, whether present as impurities or additives, must be taken into account if they exceed the limits laid down in the following paragraphs.  2. The concentrations expressed below in percentages by weight refer to the total weight of the preparation.  3.    (a) Preparations shall be considered toxic if they contain:      - a solvent or mixture of solvents classified as toxic by Directive 73/173/EEC, the percentage of each solvent being calculated in relation to the total weight of the preparation as referred to in paragraph 2 above, or           - one or more of the substances classified as toxic in Annex I to this Directive, in a concentration exceeding the limit value corresponding to the classification "toxic" for that substance, or             - one or more of the substances listed in neither Annex I to this Directive nor Directive 73/173/EEC, but classified as very toxic or toxic in Annex I to Directive 67/548/EEC and the total concentration of which is in excess of 1 %. Each substance shall be taken into consideration to calculate the total concentration only when its concentration is in excess of 0,2 %.                  (b) Preparations shall be considered harmful if they contain:      - a solvent or mixture of solvents classified as harmful by Directive 73/173/EEC, the percentage of each solvent being calculated in relation to the total weight of the preparation as referred to in paragraph 2 above, or           - one or more of the substances classified as harmful in Annex I to this Directive, in a concentration falling within the limit values corresponding to the classification "harmful" for that substance, or           - one or more of the substances listed in neither Annex I to this Directive nor Directive 73/173/EEC but classified as harmful in Annex I to Directive 67/548/EEC and the total concentration of which is in excess of 10 %. Each substance shall be taken into consideration to calculate the total concentration only when its concentration is in excess of 1 %.                  (c) Preparations shall be considered corrosive if they contain:      - a solvent or mixture of solvents classified as corrosive by Directive 73/173/EEC, the percentage of each solvent being calculated in relation to the total weight of the preparation as referred to in paragraph 2, or           - one or more of the substances classified as corrosive in Annex I to this Directive in a concentration exceeding the limit values corresponding to the classification "corrosive" for that substance, or           - one or more of the substances listed in neither Annex I to this Directive nor Directive 73/173/EEC but classified as corrosive in Annex I to Directive 67/548/EEC and the total concentration of which is in excess of 5 %. Each substance shall be taken into consideration to calculate the total concentration only when its concentration is in excess of 1 %.                  (d) Preparations shall be considered irritant if the contain:      - a solvent or mixture of solvents classified as irritant by Directive 73/173/EEC, the percentage of each solvent being calculated in relation to the total weight of the preparation as referred to in paragraph 2, or           - one or more of the substances classified as irritant in Annex I to this Directive in a concentration falling within the limit values corresponding to the classification "irritant" for that substance, or           - one or more of the substances listed in neither Annex I to this Directive nor Directive 73/173/EEC but classified as irritant in Annex I to Directive 67/548/EEC and the total concentration of which is in excess of 5 %. Each substance shall be taken into consideration to calculate the total concentration only when its concentration is in excess of 2 %.                  (e) Preparations shall be considered oxidizing if they contain:      - one or more of the substances classified as oxidizing in Annex I to this Directive, in a concentration exceeding the limit values corresponding to the classification "oxidizing" for that substance, or           - one or more of the substances not listed in Annex I to this Directive but classified as oxidizing in Annex I to Directive 67/548/EEC  and the total concentration of which is in excess of 25 %.                  (f) The following shall be considered extremely flammable:  preparations in liquid form having a flash point, determined in accordance with one of the test methods laid down in Part A of Annex V to Directive 67/548/EEC, lower than 0 °C and the boiling point of which is lower than or equal to 35 °C.       (g) The following shall be considered highly flammable:  preparations in liquid form having a flash point, determined in accordance with one of the test methods laid down in Part A of Annex V to Directive 67/548/EEC, below 21 °C.       (h) The following shall be considered flammable:  preparations in liquid form having a flash point, determined in accordance with one of the test methods laid down in Part A of Annex V to Directive 67/548/EEC, equal to or greater than 21 °C and less than or equal to 55 °C.         4. Preparations in the form of aerosols shall be subject to the flammability criteria set out in paragraphs 1.8 and 2.2 (c) of the Annex to Directive 75/324/EEC.  Article 4 Member States shall take all necessary measures to ensure that the preparations referred to in Article 1 shall not be placed on the market unless they comply with the provisions of this Directive and the Annexes hereto.  Article 5 Member States shall take all necessary measures to ensure that dangerous preparations (paints, varnishes, printing inks, adhesives and similar products) are not placed on the market unless their packages and fastenings comply with the requirements of Article 15 of Directive 67/548/EEC.  Article 6 1. Member States shall take all necessary measures to ensure that the preparations referred to in Article 1 shall not be placed on the market unless their package complies with the following labelling requirements.  2. Any package of a preparation considered dangerous within the meaning of Article 3 shall show clearly and indelibly the following:    (a) the trade name or designation of the preparation;       (b) the chemical name(s) of the very toxic, toxic, harmful and/or corrosive constituent(s) of the preparation, if its/their concentration exceeds the lowest limits specified in Article 3;  the chemical name of any irritant constituents, if their concentration exceeds the lowest limits specified in Article 3, where the preparation does not otherwise contain very toxic, toxic, harmful or corrosive constituents;  the chemical name(s) of the very toxic or toxic solvent(s) of which more than 0,2 % is present in the preparation and the chemical name(s) of the harmful, corrosive and irritant solvents in accordance with the Article 5 (2) (b) of Directive 73/173/EEC, the percentage of each solvent being calculated in relation to the total weight of the preparation;  the chemical name shall be one of the terms listed in Annex I to Directive 67/548/EEC;  the chemical name(s) of the substance(s) referred to in the preceding subparagraphs need not be stated if the preparation is classified only as extremely flammable, highly flammable or flammable;       (c) the name and address of the manufacturer or of any other person placing the preparation on the market;       (d) symbols where specified in this Directive and indications of the dangers involved in the use of the preparation in accordance with Article 16 (2) (c) of Directive 67/548/EEC, read in conjunction with Annex V thereto, and in the case of aerosol preparations, in accordance with paragraphs 1.8 and 2.2 (c) of the Annex to Directive 75/324/EEC where flammability hazards are concerned;        (e) one or more standard phrases indicating the special risks involved in the use of the preparation;       (f) one or more standard phrases indicating the safety advice relating to the use of the preparation.         3. The indications concerning special risks shall conform to the wording in Annex III to Directive 67/548/EEC and shall be selected by the manufacturer or any other person placing the preparation on the market, or, in the case of a preparation subject to approval, by the competent authority. If the preparation falls within several danger categories, these indications shall cover all the principal hazards associated with the preparation. No more than four standard indications need be shown.  4. The indications concerning safety advice shall conform to the wording in Annex IV to Directive 67/548/EEC and shall be selected by the manufacturer or any other person placing the preparation on the market, or, in the case of a preparation subject to approval, by the competent authority. No more than four standard indications need be shown.  5. The package shall be accompanied by safety advice on the use of the preparation where it is physically impossible for this to be given on the label or package itself.  6. For irritant, highly flammable, flammable and oxidizing preparations, it is not necessary to indicate the special risks and safety advice if the package contains no more than 125 ml. This shall also apply in the case of harmful preparations of the same volume not retailed to the general public. Unless otherwise indicated, this limit shall not apply to the preparations listed in Annex II hereto.  In the case of preparations containing substances listed in Annex II, the indications specified therein shall also be shown.  The safety advice required for preparations intended for spraying shall be indicated.  7. Where a preparation is assigned more than one danger symbol:    - "X" and "C" symbols are not necessarily required if a "T" symbol is indicated, unless Annex I provides otherwise,       - an "X" symbol is not necessarily required if a "C" symbol is indicated,       - "F" and "O" symbols are not necessarily required if an "E" symbol is indicated.         8. If a preparation is classified as both harmful and irritant, it shall be labelled harmful and attention shall be drawn to its harmful and irritant characteristics by appropriate warnings in accordance with Annex III to Directive 67/548/EEC.  9. Indications such as "non-toxic" and "non-harmful" or any other similar indications must not appear on the label or packaging of preparations subject to this Directive.  Article 7 1. Where the particulars required by Article 6 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that these particulars can be read horizontally when the package is set down normally. The dimensions of the label shall be as follows:  Capacity of the package : Dimensions (in millimetres) if possible    - not exceeding three litres : at least 52 × 74,       - greater than three litres but not exceeding 50 litres : at least 74 × 105,       - greater than 50 litres but not exceeding 500 litres : at least 105 × 148,       - greater than 500 litres : at least 148 × 210.         Each symbol shall cover at least one tenth of the surface area of the label but not be less than 1 cm2. The entire surface of the label shall  adhere to the package immediately containing the preparation.  These dimensions are intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety indications.  2. A label is not required where the particulars are clearly shown on the package itself, as specified in paragraph 1.  3. The colour and presentation of the label - or, in the case of paragraph 2, of the package - shall be such that the danger symbol and its background stand out clearly from it.  4. Member States may make the placing on the market of dangerous preparations in their territories subject to the use of the official language or languages in respect of the labelling thereof.  5. For the purpose of this Directive, labelling requirements shall be deemed to be satisfied:    (a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous substances and the inner package or packages are labelled in accordance with this Directive:       (b) in the case of a single package, if such a package is labelled in accordance with international rules on the transport of dangerous substances and with Article 6 (2) (a), (b), (c), (e) and (f).         Where dangerous preparations do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous substances.  Article 8 1. Member States may:    (a) permit the labelling required under Article 6 to be applied in some other appropriate manner on packages too small, or otherwise unsuitable, to allow labelling in accordance with Article 7 (1) and (2);       (b) by way of derogation from Articles 6 and 7, permit the packages of preparations other than very toxic or toxic preparations to be labelled in some other way if they contain small quantities presenting no danger to persons handling the preparation or otherwise concerned.         2. Member States acting under the foregoing paragraph 1 shall immediately inform the Commission thereof.  Article 9 Member States shall not prohibit, restrict or impede, on the grounds of classification, packaging or labelling as defined in this Directive, the placing on the market of dangerous preparations which satisfy the requirements of this Directive and the Annexes hereto.  Article 10 1. Where a Member State has detailed grounds for establishing that a dangerous preparation, although satisfying the requirements of this Directive, presents a health or safety risk, it may, provisionally, prohibit the sale of that preparation or subject it to special conditions within its territory. It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision.  2. The Commission shall, within six weeks, consult with the Member States concerned, express its opinion without delay and take appropriate steps.  3. If the Commission is of the opinion that technical amendments to the Directive are required, these amendments shall be adopted, by either the Commission or the Council, in accordance with the procedure laid down in Article 21 of Directive 67/548/EEC. In this event, the Member State which has introduced safeguard measures may maintain them until such amendments enter into force.  Article 11 The amendments required for adapting the Annexes to this Directive to technical progress shall be adopted in accordance with the  procedure laid down in Article 21 of Directive 67/548/EEC.  Methods of analysis shall also be adopted by the same procedure."    Article 2 1. Member States shall introduce the laws, regulations and administrative provisions necessary to comply with this Directive within 12 months of its notification and shall inform the Commission immediately thereof (1).  2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 16 May 1983.  For the Council  The President  I. KIECHLE  (1) This Directive was notified to the Member States on 19 May 1983.