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32001L0113

Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption

Official Journal L 010 , 12/01/2002 P. 0067 - 0072

Council Directive 2001/113/ECof 20 December 2001relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumptionTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 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:(1) Certain vertical Directives relating to foodstuffs should be simplified in order to take account only of the essential requirements to be met by the products they cover so that those products may move freely within the internal market, in accordance with the conclusions of the European Council meeting in Edinburgh on 11 and 12 December 1992, as confirmed by those of the European Council meeting in Brussels on 10 and 11 December 1993.(2) Council Directive 79/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée(4) was justified by the fact that differences between national laws relating to the products concerned could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market.(3) Directive 79/693/EEC was consequently designed to lay down definitions and common rules governing composition, manufacturing specifications and labelling of the products concerned, so as to ensure their free movement within the Community.(4) Directive 79/693/EEC should be brought into line with general Community legislation on foodstuffs, and in particular legislation on labelling, colouring agents, sweeteners and other authorised additives and, for the sake of clarity, should be recast in order to make the rules on the conditions for the production and marketing of fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption more accessible.(5) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council(5) should apply subject to certain conditions.(6) In order to take account of existing national traditions in the making of fruit jams, jellies and marmalades and sweetened chestnut purée, it is necessary to maintain existing national regulations authorising the marketing of such products with a reduced sugar content.(7) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve the said objective.(8) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6).(9) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive,HAS ADOPTED THIS DIRECTIVE:Article 1This Directive shall apply to the products defined in Annex I.It shall not apply to products intended for the manufacture of fine bakery wares, pastries or biscuits.Article 2Directive 2000/13/EC shall apply to the products defined in Annex I hereto, subject to the following conditions:1. The product names listed in Annex I shall apply only to the products referred to therein and shall be used in trade to designate them.The product names used in Annex I may, however, be used in addition to the name and in accordance with practices used to designate other products which cannot be confused with those defined in Annex I.2. The product names shall be supplemented by an indication of the fruit or fruits used, in descending order of weight of the raw materials used. However, for products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words "mixed fruit" or a similar wording, or by the number of fruits used.3. The labelling shall indicate the fruit content by including the words "prepared with ... g of fruit per 100 g" of the finished product, after deduction of the weight of water used in preparing the aqueous extracts, if appropriate.4. The labelling shall indicate the total sugar content by the words "total sugar content ... g per 100 g", the figure indicated representing the value determined by refractometer at 20 °C for the finished product, subject to a tolerance of ± 3 refractometric degrees.The sugar content need not, however, be indicated where a nutrition claim is made for sugars on the labelling pursuant to Directive 90/496/EEC(7).5. The particulars referred to in point 3 and the first subparagraph of point 4 shall appear in the same visual field as the product name and in clearly visible characters.6. Where the residual content of sulphur dioxide is more than 10 mg/kg, its presence shall be indicated on the list of ingredients by way of derogation from Article 6(4) of Directive 2000/13/EC.Article 3For the products defined in Annex I, Member States shall not adopt national provisions not provided for by this Directive.Article 4Without prejudice to Directive 89/107/EEC(8) or to provisions adopted in order to give it effect, only the ingredients listed in Annex II hereto and raw materials which comply with Annex III hereto may be used in the manufacture of the products defined in Annex I hereto.Article 5The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 6(2):- bringing this Directive into line with general Community legislation on foodstuffs,- adaptations to technical progress.Article 61. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee") set up by Article 1 of Decision 69/414/EEC(9).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 7Directive 79/693/EEC is hereby repealed with effect from 12 July 2003.References to the repealed Directive shall be construed as references to this Directive.Article 8Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 12 July 2003. They shall forthwith inform the Commission thereof.The measures shall be applied so as to:- authorise the marketing of the products defined in Annex I if they comply with the definitions and rules laid down in this Directive, with effect from 12 July 2003,- prohibit the marketing of products which do not comply with this Directive, with effect from 12 July 2004.However, the marketing of products which fail to conform to this Directive but which were labelled before 12 July 2004 in accordance with Directive 79/693/EEC shall be permitted until stocks run out.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be adopted by Member States.Article 9This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 10This Directive is addressed to the Member States.Done at Brussels, 20 December 2001.For the CouncilThe PresidentC. Picqué(1) OJ C 231, 9.8.1996, p. 27.(2) OJ C 279, 1.10.1999, p. 95.(3) OJ C 56, 24.2.1997, p. 20.(4) OJ L 205, 13.8.1979, p. 5. Directive as last amended by Directive 88/593/EEC (OJ L 318, 25.11.1988, p. 44).(5) OJ L 109, 6.5.2000, p. 29.(6) OJ L 184, 17.7.1999, p. 23.(7) OJ L 276, 6.10.1990, p. 40.(8) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).(9) OJ L 291, 19.11.1969, p. 9.ANNEX INAMES, PRODUCT DESCRIPTIONS AND DEFINITIONSI. DEFINITIONS- "Jam" is a mixture, brought to a suitable gelled consistency, of sugars, the pulp and/or purée of one or more kinds of fruit and water. However, citrus jam may be obtained from the whole fruit, cut into strips and/or sliced.>TABLE>- "Extra jam" is a mixture, brought to a suitable gelled consistency, of sugars, the unconcentrated pulp of one or more kinds of fruit and water. However, rosehip extra jam and seedless raspberry, blackberry, blackcurrant, blueberry and redcurrant extra jam may be obtained entirely or in part from unconcentrated purée of the respective fruits. Citrus extra jam may be obtained from the whole fruit, cut into strips and/or sliced.The following fruits may not be used mixed with others in the manufacture of extra jam: apples, pears, clingstone plums, melons, water-melons, grapes, pumpkins, cucumbers and tomatoes.>TABLE>- "Jelly" is an appropriately gelled mixture of sugars and the juice and/or aqueous extracts of one or more kinds of fruit.The quantity of juice and/or aqueous extracts used in the manufacture of 1000 g of finished product must not be less than that laid down for the manufacture of jam. These quantities are calculated after deduction of the weight of water used in preparing the aqueous extracts.- In the case of "extra jelly", however, the quantity of fruit juice and/or aqueous extracts used in the manufacture of 1000 g of finished product must not be less than that laid down for the manufacture of extra jam. These quantities are calculated after deduction of the weight of water used in preparing the aqueous extracts. The following fruits may not be used mixed with others in the manufacture of extra jelly: apples, pears, clingstone plums, melons, water-melons, grapes, pumpkins, cucumbers and tomatoes.- "Marmalade" is a mixture, brought to a suitable gelled consistency, of water, sugars and one or more of the following products obtained from citrus fruit: pulp, purée, juice, aqueous extracts and peel.The quantity of citrus fruit used in the manufacture of 1000 g of finished product must not be less than 200 g of which at least 75 g must be obtained from the endocarp.- The name "jelly marmalade" may be used where the product contains no insoluble matter except possibly for small quantities of finely sliced peel.- "Sweetened chestnut purée" is a mixture, brought to a suitable consistency, of water, sugar and at least 380 g of chestnut (Castanea sativa) purée for 1000 g of finished product.II. Products defined in part I must have a soluble dry matter content of 60 % or more as determined by refractometer, except for those products in respect of which sugars have been wholly or partially replaced by sweeteners.Without prejudice to Article 5(1) of Directive 2000/13/EC, Member States may, however, in order to take account of certain particular cases, authorise the reserved names for products defined in part I which have a soluble dry matter content of less than 60 %.III. Where fruits are mixed together, the minimum contents laid down in part I for different kinds of fruit must be reduced in proportion to the percentages used.ANNEX IIThe following additional ingredients may be used in the products defined in Annex I:- honey as defined in Council Directive 2001/110/EC of 20 December 2001 relating to honey(1): in all products as a total or partial substitute for sugars,- fruit juice: only in jam,- citrus fruit juice: in products obtained from other types of fruit: only in jam, extra jam, jelly and extra jelly,- red fruit juices: only in jam and extra jam manufactured from rosehips, strawberries, raspberries, gooseberries, redcurrants, plums and rhubarb,- red beetroot juice: only in jam and jelly manufactured from strawberries, raspberries, gooseberries, redcurrants and plums,- essential oils of citrus fruits: only in marmalade and jelly marmalade,- edible oils and fats as anti-foaming agents: in all products,- liquid pectin: in all products,- citrus peel: in jam, extra jam, jelly and extra jelly,- leaves of Pelargonium odoratissimum: in jam, extra jam, jelly and extra jelly, where they are made from quince,- spirits, wine and liqueur wine, nuts, aromatic herbs, spices, vanilla and vanilla extracts: in all products,- vanilline: in all products.(1) See page 47 of this Official Journal.ANNEX IIIA. DEFINITIONSFor the purposes of this Directive, the following definitions shall apply:1. Fruit:- fresh, sound fruit, free from deterioration, containing all its essential constituents and sufficiently ripe for use, after cleaning, removal of blemishes, topping and tailing,- for the purposes of this Directive, tomatoes, the edible parts of rhubarb stalks, carrots, sweet potatoes, cucumbers, pumpkins, melons and water-melons are considered to be fruit,- "ginger" means the edible root of the ginger plant in a fresh or preserved state. Ginger may be dried or preserved in syrup.2. (Fruit) pulp:The edible part of the whole fruit, if appropriate, less the peel, skin, seeds, pips and the like, which may have been sliced or crushed but which has not been reduced to a purée.3. (Fruit) purée:The edible part of the whole fruit, if necessary, less the peel, skin, seeds, pips and the like, which has been reduced to a purée by sieving or a similar process.4. Aqueous extracts (of fruit):The aqueous extract of fruits which, subject to the losses necessarily occurring in proper manufacturing, contains all the water-soluble constituents of the fruit used.5. SugarsAuthorised sugars are:1. the sugars as defined in Directive 2001/111/EC(1);2. fructose syrup;3. sugars extracted from fruit;4. brown sugar.B. TREATMENT OF RAW MATERIALS1. The products defined in items 1, 2, 3 and 4 of part A may be treated in the following ways:- heated, chilled or frozen,- freeze-dried,- concentrated, to the extent that is technically possible,- with the exception of the raw materials used in the manufacture of "extra" products: the use of sulphur dioxide (E 220) or its salts (E 221, E 222, E 223, E 224, E 226 and E 227) as an aid to manufacture provided that the maximum sulphur-dioxide content laid down in Directive 95/2/EC is not exceeded in the products defined in part I of Annex I.2. Apricots and plums to be used in the manufacture of jam may also be treated by other drying processes apart from freeze-drying.3. Citrus peel may be preserved in brine.(1) See page 53 of this Official Journal.


title: Commission Directive 2007/12/EC of 26 February 2007 amending certain Annexes to Council Directive 90/642/EEC as regards the maximum residue levels of penconazole, benomyl and carbendazim (Text with EEA relevance)

text:
               27.2.2007

               EN

               Official Journal of the European Union

               L 59/75

      COMMISSION DIRECTIVE 2007/12/EC
   of 26 February 2007
   amending certain Annexes to Council Directive 90/642/EEC as regards the maximum residue levels of penconazole, benomyl and carbendazim
   (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 penconazole, benomyl and carbendazim.

               (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 (3).

               (5)

               In the case of benomyl and carbendazim 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, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides (4), 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)

               In the case of the new MRL on citrus for benomyl and carbendazim the applicant has undertaken to supply additional data required by December 2007. The data already available show that the proposed MRL is safe for the consumers.

               (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)

               Directive 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
   Annex II to Directive 90/642/EEC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 27 August 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 28 August 2007.
   2.   When Member States adopt the provisions referred to in paragraph 1, 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.
   3.   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, 26 February 2007.

            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 2006/92/EC (OJ L 311, 10.11.2006, p. 31).

      (2)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/6/EC (OJ L 43, 15.2.2007, p. 13).

      (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)  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
      In part A of Annex II to Directive 90/642/EEC, the columns for penconazole, benomyl, and carbendazim 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

                     Penconazole

                     Sum of benomyl and carbendazim, expressed as carbendazim

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

                                 (i)

                                 CITRUS FRUIT

                     0,05 (1)

                     0,5 (2)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,05 (1)

                     0,1 (1)

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     Others

                                 (iii)

                                 POME FRUIT

                     0,2

                     0,2

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     Apricots

                     0,1

                     0,2

                     Cherries

                     0,5

                     Peaches (including nectarines and similar hybrids)

                     0,1

                     0,2

                     Plums

                     0,5

                     Others

                     0,05 (1)

                     0,1 (1)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     0,2

                     Table grapes

                     0,3

                     Wine grapes

                     0,5

                                 (b)

                                 Strawberries (other than wild)

                     0,5

                     0,1 (1)

                                 (c)

                                 Cane fruit (other than wild)

                     0,05 (1)

                     0,1 (1)

                     Blackberries

                     Dewberries

                     Loganberries

                     Raspberries

                     Others

                                 (d)

                                 Other small fruit and berries (other than wild)

                     0,1 (1)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     0,5

                     Gooseberries

                     Others

                     0,05 (1)

                                 (e)

                                 Wild berries and wild fruit

                     0,05 (1)

                     0,1 (1)

                                 (vi)

                                 MISCELLANEOUS

                     0,05 (1)

                     Avocados

                     Bananas

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     Olives (table consumption)

                     Olives (oil extraction)

                     Papaya

                     0,2

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                     0,1 (1)

               2.   Vegetables, fresh or uncooked, frozen or dry

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,05 (1)

                     0,1 (1)

                     Beetroot

                     Carrots

                     Cassava

                     Celeriac

                     Horseradish

                     Jerusalem artichokes

                     Parsnips

                     Parsley root

                     Radishes

                     Salsify

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                                 (ii)

                                 BULB VEGETABLES

                     0,05 (1)

                     0,1 (1)

                     Garlic

                     Onions

                     Shallots

                     Spring onions

                     Others

                                 (iii)

                                 FRUITING VEGETABLES

                                 (a)

                                 Solanacea

                     Tomatoes

                     0,1

                     0,5

                     Peppers

                     0,2

                     Aubergines

                     0,1

                     0,5

                     Okra

                     2

                     Others

                     0,05 (1)

                     0,1 (1)

                                 (b)

                                 Cucurbits — edible peel

                     0,1

                     0,1 (1)

                     Cucumbers

                     Gherkins

                     Courgettes

                     Others

                                 (c)

                                 Cucurbits — inedible peel

                     0,1

                     0,1 (1)

                     Melons

                     Squashes

                     Watermelons

                     Others

                                 (d)

                                 Sweet corn

                     0,05 (1)

                     0,1 (1)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,05 (1)

                                 (a)

                                 Flowering brassica

                     0,1 (1)

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     0,5

                     Head cabbage

                     Others

                     0,1 (1)

                                 (c)

                                 Leafy brassica

                     0,1 (1)

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                     0,1 (1)

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,05 (1)

                     0,1 (1)

                                 (a)

                                 Lettuce and similar

                     Cress

                     Lamb's lettuce

                     Lettuce

                     Scarole (broadleaf endive)

                     Rucola

                     Leaves and stems of brassica

                     Others

                                 (b)

                                 Spinach and similar

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Water cress

                                 (d)

                                 Witloof

                                 (e)

                                 Herbs

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,05 (1)

                     Beans (with pods)

                     0,2

                     Beans (without pods)

                     Peas (with pods)

                     0,2

                     Peas (without pods)

                     Others

                     0,1 (1)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,1 (1)

                     Asparagus

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     0,2

                     Leek

                     Rhubarb

                     Others

                     0,05 (1)

                                 (viii)

                                 FUNGI

                     0,05 (1)

                     0,1 (1)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,05 (1)

                     0,1 (1)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

                                 4.

                                 Oilseeds

                     0,05 (1)

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rape seed

                     Soya bean

                     0,2

                     Mustard seed

                     Cotton seed

                     Hemp seed

                     Others

                     0,1 (1)

                                 5.

                                 Potatoes

                     0,05 (1)

                     0,1 (1)

                     Early potatoes

                     Ware potatoes

                                 6.

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

                     0,1 (1)

                     0,1 (1)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     0,5

                     0,1 (1)

         (1)  Indicates lower limit of analytical determination.

         (2)  Indicates that the maximum residue level has been established temporarily until 31 December 2007 pending data to be submitted by the applicant. If no data have been received by that date, the MRL will be withdrawn by a Directive or a Regulation.’


title: Commission Directive (EU) 2015/1480 of 28 August 2015 amending several annexes to Directives 2004/107/EC and 2008/50/EC of the European Parliament and of the Council laying down the rules concerning reference methods, data validation and location of sampling points for the assessment of ambient air quality (Text with EEA relevance)

text:
               29.8.2015

               EN

               Official Journal of the European Union

               L 226/4

         COMMISSION DIRECTIVE (EU) 2015/1480
   of 28 August 2015
   amending several annexes to Directives 2004/107/EC and 2008/50/EC of the European Parliament and of the Council laying down the rules concerning reference methods, data validation and location of sampling points for the assessment of ambient air quality
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2004/107/EC of the European Parliament and of the Council of 15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air (1), and in particular Article 4(15) thereof,
   Having regard to Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air quality and cleaner air for Europe (2), and in particular Article 28(1) thereof,
   Whereas:

               (1)

               In accordance with Article 4(15) of Directive 2004/107/EC, as amended by Regulation (EC) No 219/2009/EC of the European Parliament and of the Council (3), the Commission is empowered to amend certain provisions of Annexes IV and V.

               (2)

               Annex IV to Directive 2004/107/EC, lays down data quality objectives that need to be updated in order to achieve better clarity.

               (3)

               Annex V to Directive 2004/107/EC lays down the reference methods for assessment of concentrations, and such methods should be updated in order to reflect the development of the relevant standards.

               (4)

               In accordance with Article 28(1) of Directive 2008/50/EC the Commission is empowered to amend certain provisions of Annexes I, III, VI and IX.

               (5)

               Section C of Annex I to Directive 2008/50/EC lays down criteria for the quality assurance for ambient air quality assessment, which need to be clarified and complemented taking into account the quality assurance programmes organised by the Commission's Joint Research Centre and introducing the obligation of reviewing the quality control system in order to ensure the continued accuracy of monitoring devices.

               (6)

               Sections C and D of Annex III to Directive 2008/50/EC lay down criteria for the siting of sampling points, which need to be clarified and complemented in the light of the experience gained in implementing the Directive.

               (7)

               Section A of Annex VI to Directive 2008/50/EC lays down the reference method for the measurement of certain pollutants, which need to be adapted having regard to the experience gained in implementing the Directive and taking into account the most recent standards for the sampling and measurement of particulate matter.

               (8)

               In accordance with the Joint Political Declaration of Member States and the Commission of 28 September 2011 on explanatory documents (4), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Ambient Air Quality Committee,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes IV and V to Directive 2004/107/EC are amended in accordance with Annex I to this Directive.
   Article 2
   Annexes I, III, VI and IX to Directive 2008/50/EC are amended in accordance with Annex II to this Directive.
   Article 3
   The provisions of this Directive should be read in conjunction with those of Regulation (EC) No 765/2008 of the European Parliament and of the Council (5), in particular as regards the accreditation of conformity assessment bodies, and do not introduce any derogation or exception to the above Regulation.
   Article 4
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2016 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   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 5
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 28 August 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 23, 26.1.2005, p. 3.

      (2)  OJ L 152, 11.6.2008, p. 1.

      (3)  Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two (OJ L 87, 31.3.2009, p. 109).

      (4)  OJ C 369, 17.12.2011, p. 14.

      (5)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

      ANNEX I
      Directive 2004/107/EC is amended as follows:

                  (1)

                  Section I of Annex IV is amended as follows:

                              (a)

                              the table is replaced by the following:

                                          ‘Benzo(a)pyrene

                                          Arsenic, cadmium and nickel

                                          Polycyclic aromatic hydrocarbons other than benzo(a)pyrene, total gaseous mercury

                                          Total deposition

                                                      —

                                                      Uncertainty

                                          Fixed and indicative measurements

                                          50 %

                                          40 %

                                          50 %

                                          70 %

                                          Modelling

                                          60 %

                                          60 %

                                          60 %

                                          60 %

                                                      —

                                                      Minimum data capture

                                          90 %

                                          90 %

                                          90 %

                                          90 %

                                                      —

                                                      Minimum time coverage

                                          Fixed measurements (1)

                                          33 %

                                          50 %

                                          Indicative measurements (1)
                                              (2)

                                          14 %

                                          14 %

                                          14 %

                                          33 %

                              (b)

                              in the third paragraph, the following sentence is deleted:
                              ‘Twenty-four hour sampling is also advisable for the measurement of arsenic, cadmium and nickel concentrations.’

                              (c)

                              after the third paragraph the following text is inserted:
                              ‘The provisions on individual samples in the previous paragraph apply also to arsenic, cadmium, nickel and total gaseous mercury. Moreover, sub–sampling of PM10 filters for metals for subsequent analysis is allowed, providing there is evidence that the sub-sample is representative of the whole and that the detection sensitivity is not compromised when compared with the relevant data quality objectives. As an alternative to daily sampling, weekly sampling for metals in PM10 is allowed provided that the collection characteristics are not compromised.’

                  (2)

                  Sections I to IV of Annex V are replaced by the following:
                  ‘I.   Reference method for the sampling and analysis of arsenic, cadmium and nickel in ambient air

                  The reference method for the sampling of arsenic, cadmium and nickel in ambient air is described in EN 12341:2014. The reference method for the measurement of arsenic, cadmium and nickel in ambient air is that described in EN 14902:2005 “Ambient air quality — Standard method for the measurement of Pb, Cd, As and Ni in the PM10 fraction of suspended particulate matter”.
                  A Member State may also use any other methods which it can demonstrate give results equivalent to the above method.
                  II.   Reference method for the sampling and analysis of polycyclic aromatic hydrocarbons in ambient air

                  The reference method for the sampling of polycyclic aromatic hydrocarbons in ambient air is described in EN 12341:2014. The reference method for the measurement of benzo(a)pyrene in ambient air is that described in EN 15549:2008 “Air quality — Standard method for the measurement of concentration of benzo[a]pyrene in ambient air”. In the absence of a CEN standard method for the other polycyclic aromatic hydrocarbons referred to in Article 4(8), Member States are allowed to use national standards methods or ISO methods such as ISO standard 12884.
                  A Member State may also use any other method which it can demonstrate give results equivalent to the above method.
                  III.   Reference method for the sampling and analysis of mercury in ambient air

                  The reference method for the measurement of total gaseous mercury concentrations in ambient air is that described in EN 15852:2010 “Ambient air quality — Standard method for the determination of total gaseous mercury”.
                  A Member State may also use any other method which it can demonstrate give results equivalent to the above method.
                  IV.   Reference method for the sampling and analysis of the deposition of arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons

                  The reference method for the determination of the deposition of arsenic, cadmium, and nickel is that described in EN 15841:2009 “Ambient air quality — Standard method for determination of arsenic, cadmium, lead and nickel in atmospheric deposition”.
                  The reference method for the determination of the deposition of mercury is that described in EN 15853:2010 “Ambient air quality — Standard method for determination of mercury deposition”.
                  The reference method for the determination of the deposition of benzo(a)pyrene and the other polycyclic hydrocarbons referred to in Article 4(8) is that described in EN 15980:2011 “Air quality. Determination of the deposition of benz[a]anthracene, benzo[b]fluoranthene, benzo[j]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, dibenz[a,h]anthracene and indeno[1,2,3-cd]pyrene”.’

         (1)  Distributed over the year to be representative of various conditions for climate and anthropogenic activities

         (2)  Indicative measurement being measurements which are performed at reduced regularity but fulfil the other data quality objectives’

      ANNEX II
      Directive 2008/50/EC is amended as follows:

                  (1)

                  Section C of Annex I is replaced by the following:
                  ‘C.   Quality assurance for ambient air quality assessment. Data validation

                              1.

                              To ensure accuracy of measurements and compliance with the data quality objectives laid down in Section A, the appropriate competent authorities and bodies designated pursuant to Article 3 shall ensure the following:

                                          (i)

                                          that all measurements undertaken in relation to the assessment of ambient air quality pursuant to Articles 6 and 9 are traceable in accordance with the requirements set out in the harmonised standard for testing and calibration laboratories,

                                          (ii)

                                          that institutions operating networks and individual stations have an established quality assurance and quality control system which provides for regular maintenance to assure the continued accuracy of measuring devices. The quality system shall be reviewed as necessary and at least every five years by the relevant National Reference Laboratory

                                          (iii)

                                          that a quality assurance/quality control process is established for the process of data collection and reporting and that institutions appointed for this task actively participate, in the related Union-wide quality assurance programmes,

                                          (iv)

                                          that the National Reference Laboratories are appointed by the appropriate competent authority or body designated pursuant to Article 3 and are accredited for the reference methods referred to in Annex VI, at least for those pollutants for which concentrations are above the lower assessment threshold, according to the relevant harmonised standard for testing and calibration laboratories, the reference to which has been published in the Official Journal of the European Union pursuant to Article 2(9) of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance. These laboratories shall also be responsible for the coordination in Member State's territory of the Union-wide quality assurance programmes to be organised by the Commission's Joint Research Centre and shall also be responsible for coordinating, on the national level, the appropriate use of reference methods, and the demonstration of equivalence of non-reference methods. National Reference Laboratories organising intercomparison on the national level should also be accredited according to the relevant harmonised standard for proficiency testing.

                                          (v)

                                          that the National Reference Laboratories, take part at least every three years in the Union-wide quality assurance programmes organized by the Commission's Joint Research Centre. If this participation produces unsatisfactory results then the national laboratory should demonstrate at the next participation in the intercomparison satisfactory remediation measures, and provide a report to the Joint Research Centre on these.

                                          (vi)

                                          that the national reference laboratories support the work done by the European network of National Reference Laboratories set up by the Commission.

                              2.

                              All reported data under Article 27 shall be deemed to be valid except data flagged as provisional.’

                  (2)

                  Annex III is amended as follows:

                              (a)

                              Section C is amended as follows:

                                          (i)

                                          the first and the second indents of paragraph 1 are replaced by the following:

                                                      ‘—

                                                      the flow around the inlet sampling probe shall be unrestricted (in general free in an arc of at least 270° or 180° for sampling points at the building line) without any obstructions affecting the airflow in the vicinity of the inlet (normally some metres away from buildings, balconies, trees and other obstacles and at least 0,5 m from the nearest building in the case of sampling points representing air quality at the building line)

                                                      —

                                                      in general, the inlet sampling point shall be between 1,5 m (the breathing zone) and 4 m above the ground. Higher siting may also be appropriate if the station is representative of a large area and any derogations should be fully documented;’

                                          (ii)

                                          the fifth indent of paragraph 1 is replaced by the following:

                                                      ‘—

                                                      for all pollutants, traffic-orientated sampling probes shall be at least 25 m from the edge of major junctions and no more than 10 m from the kerbside. A “major junction” to be considered here is a junction which interrupts the traffic flow and causes different emissions (stop&go) from the rest of the road.’

                                          (iii)

                                          the following paragraph is added:
                                          ‘Any deviation from the criteria listed in this Section shall be fully documented through the procedures described in Section D.’

                              (b)

                              Section D is replaced by the following:
                              ‘D.   Documentation and review of site selection

                              The competent authorities responsible for air quality assessment shall for all zones and agglomerations fully document the site-selection procedures and record information to support the network design and choice of location for all monitoring sites. The documentation shall include compass-point photographs of the area surrounding monitoring sites and detailed maps. Where supplementary methods are used within a zone or agglomeration, the documentation shall include details of these methods and information on how the criteria listed in Article 7(3) are met. The documentation shall be updated as necessary and reviewed at least every 5 years, to ensure that selection criteria, network design and monitoring site locations remain valid and optimal over time. The documentation shall be provided to the Commission within 3 months of being requested.’

                  (3)

                  Annex VI is amended as follows:

                              (a)

                              Section A is replaced by the following:
                              ‘A.   Reference methods for the assessment of concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter (PM10 and PM2,5), lead, benzene, carbon monoxide and ozone

                              1.   Reference method for the measurement of sulphur dioxide

                              The reference method for the measurement of sulphur dioxide is that described in EN 14212:2012 “Ambient air — Standard method for the measurement of the concentration of sulphur dioxide by ultraviolet fluorescence”.
                              2.   Reference method for the measurement of nitrogen dioxide and oxides of nitrogen

                              The reference method for the measurement of nitrogen dioxide and oxides of nitrogen is that described in EN 14211:2012 “Ambient air — Standard method for the measurement of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminescence”.
                              3.   Reference method for the sampling and measurement of lead — unchanged

                              4.   Reference method for the sampling and measurement of PM10

                              The reference method for the sampling and measurement of PM10 is that described in EN12341:2014 “Ambient Air — standard gravimetric measurement method for the determination of the PM10 or PM2,5 mass concentration of suspended particulate matter”.
                              5.   Reference method for the sampling and measurement of PM2,5

                              The reference method for the sampling and measurement of PM2,5 is that described in EN12341:2014 “Ambient Air — standard gravimetric measurement method for the determination of the PM10 or PM2,5 mass concentration of suspended particulate matter”
                              6.   Reference method for the sampling and measurement of benzene — unchanged

                              7.   Reference method for the measurement of carbon monoxide

                              The reference method for the measurement of carbon monoxide is that described in EN 14626:2012 “Ambient air — Standard method for the measurement of the concentration of carbon monoxide by non-dispersive infrared spectroscopy”.
                              8.   Reference method for measurement of ozone

                              The reference method for the measurement of ozone is that described in EN 14625:2012 “Ambient air — Standard method for the measurement of the concentration of ozone by ultraviolet photometry”.’

                              (b)

                              Section D is deleted;

                              (c)

                              Section E is replaced by the following:
                              ‘When demonstrating that equipment meets the performance requirements of the reference methods listed in Section A of this Annex, the competent authorities and bodies designated pursuant to Article 3 shall accept test reports issued in other Member States provided that the test laboratories are accredited to the relevant harmonised standard for testing and calibration laboratories.
                              The detailed test reports and all the results of the tests shall be available to other competent authorities or their designated bodies. Test reports shall demonstrate that the equipment meets all the performance requirements including where some environmental and site conditions are specific to a Member State and are outside the conditions for which the equipment has been already tested and type approved in another Member State;’

                  (4)

                  Section A of Annex IX is replaced by the following:
                  ‘A.   Minimum number of sampling points for fixed measurements of concentrations of ozone

                  Minimum number of sampling points for fixed continuous measurements to assess compliance with target values, long — term objectives and information and alert thresholds where such measurements are the sole source of information.

                              Population (× 1 000)

                              Agglomeration (1)

                              Other zones (1)

                              Rural background

                              < 250

                              1

                              1 station/50 000 km2 as an average density over all zones per country (2)

                              < 500

                              1

                              2

                              < 1 000

                              2

                              2

                              < 1 500

                              3

                              3

                              < 2 000

                              3

                              4

                              < 2 750

                              4

                              5

                              < 3 750

                              5

                              6

                              > 3 750

                              One additional station per 2 million inhabitants

                              One additional station per 2 million inhabitants

         (1)  At least 1 station in areas where exposure of the population to the highest concentrations of ozone is likely to occur. In agglomerations, at least 50 % of the stations shall be located in suburban areas.

         (2)  1 station per 25 000 km2 for complex terrain is recommended.’


title: Commission Directive (EU) 2017/774 of 3 May 2017 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards phenol (Text with EEA relevance. )

text:
               4.5.2017

               EN

               Official Journal of the European Union

               L 115/47

         COMMISSION DIRECTIVE (EU) 2017/774
   of 3 May 2017
   amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards phenol
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
   Whereas:

               (1)

               In order to ensure a high level of protection of children against risks caused by chemical substances in toys, Directive 2009/48/EC establishes certain requirements with regard to chemical substances such as those classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), allergenic fragrances and certain elements. In addition, Directive 2009/48/EC empowers the Commission to adopt specific limit values for chemicals used in toys which are intended for children under 36 months and in other toys intended to be placed in the mouth in order to ensure adequate protection in the case of toys involving a high degree of exposure. The adoption of such limit values takes the form of an inclusion in Appendix C to Annex II to Directive 2009/48/EC.

               (2)

               For a number of chemicals, currently applicable limit values are either too high in the light of available scientific evidence or do not exist. Specific limit values should therefore be adopted for them, taking into account the packaging requirements for food as well as the differences between toys and food contact materials.

               (3)

               In order to advise the European Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup ‘Chemicals’ is to provide such advice with regard to chemical substances which may be used in toys.

               (4)

               Phenol (CAS number 108-95-2) is used as a monomer for phenolic resins in the manufacture of resin-bonded wood (3) for toys. The degradation of phenolic antioxidants in polymers can be a further source of phenol in toys (4). Phenol was identified in emissions from game consoles (5), in one of six analysed tents or tunnels for children (6) and in packaging film (7), it was tested in bath toys and other inflatable toys (8), and it was considered to be present in polyvinyl chloride (PVC) (9). Phenol could further be used as a preservative in water-based liquid toys such as bubble-blowing products or water-based liquid inks (e.g. felt-tipped marker pens) (10).

               (5)

               In its deliberations on phenol the subgroup ‘Chemicals’ took European standards EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 as the basis. Those standards refer to the presence of phenol in toy materials (EN 71-9:2005+A1:2007) and provide specific methods of sample preparation (EN 71-10:2005) and measurement (EN 71-11:2005). EN 71-11:2005 repeats and details the limit values for phenol in toy materials set in EN 71-9:2005+A1:2007, namely 15 mg/l (migration limit) for phenol as a monomer and 10 mg/kg (content limit) for phenol as a preservative in liquid toy materials.

               (6)

               The subgroup ‘Chemicals’ also took account of the recommendation of the Scientific Committee on Health and Environmental Risks (SCHER) that the migration limit value of 15 mg/l for phenol set out in the existing European standard be lowered at least by a factor of 2 in order to reach a Margin of Exposure of 100 that could be considered sufficiently large (11).

               (7)

               The subgroup ‘Chemicals’ furthermore took account of the opinion of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) at the European Food Safety Authority (EFSA), which reduced the tolerable daily intake (TDI) of phenol from 1,5 mg/kg body weight per day to 0,5 mg/kg body weight per day (12).

               (8)

               Phenol is classified under Regulation (EC) No 1272/2008 as mutagenic category 2. According to point 5 of Part III of Annex II to Directive 2009/48/EC, mutagenic substances of category 2 such as phenol may be present in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it, namely 1 %, which equals 10 000 mg/kg (content limit). Directive 2009/48/EC does not currently provide for a migration limit for phenol.

               (9)

               In the light of the above, the subgroup ‘Chemicals’ recommended at its meetings of 26 March 2014 and 18 February 2015 that phenol be limited in toys to 5 mg/l (migration limit) when analysed in polymeric materials, and to a maximum concentration of 10 mg/kg (content limit) when analysed as a preservative, it being understood that 10 mg/kg (content limit) are a de facto use ban. Analyses should be carried out in accordance with European standards EN 71-10:2005 and EN 71-11:2005.

               (10)

               While there is a generic migration limit for phenol as a monomer for use in certain food contact materials, the basic assumptions for deriving that migration limit are different from those for the migration limit for phenol as a monomer in toys. The use of phenol as a preservative is not regulated for food contact materials.

               (11)

               In view of the above, Appendix C to Annex II to Directive 2009/48/EC should be amended to include a migration limit as well as a content limit for phenol in toys.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 47 of Directive 2009/48/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Appendix C to Annex II to Directive 2009/48/EC, the following entry shall be added:

                  Substance

                  CAS No

                  Limit value

                  ‘Phenol

                  108-95-2

                  5 mg/l (migration limit) in polymeric materials in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.
                  10 mg/kg (content limit) as a preservative in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.’

   Article 2
   1.   Member States shall adopt and publish, by 4 November 2018 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.
   They shall apply those provisions from 4 November 2018.
   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 twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 3 May 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 170, 30.6.2009, p. 1.

      (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

      (3)  E. Edmonds (2013) Occurrence of Phenol and Formaldehyde in Toys. Report commissioned by Toy Industries of Europe, p. 4.

      (4)  See footnote 3, pp. 5 and 8.

      (5)  Danish Environmental Protection Agency (EPA) (2003) Survey of chemical substances in consumer products Survey no. 32 — 2003. Emission and evaluation of chemical substances from selected electrical and electronic products, p. 47. http://eng.mst.dk/media/mst/69115/32.pdf

      (6)  Danish EPA (2004) Mapping of Chemical Substances in Consumer Products nr. 46, 2004. Release of chemical substances from tents and tunnels for children. http://eng.mst.dk/media/mst/69127/46.pdf

      (7)  Bundesinstitut für Risikobewertung (2009) Limit values for phenol in food-contact articles and toys are to be updated. Opinion No 038/2009, 18 August 2009. http://www.bfr.bund.de/cm/349/limit_values_for_phenol_in_food_contact_articles_and_toys_are_to_be_updated.pdf

      (8)  Voedsel en Waren Autoriteit (2004) Market Surveillances on Toy Safety. Report nr. ND04o063/01. https://www.nvwa.nl/binaries/nvwa/documenten/communicatie/inspectieresultaten/consument/2016m/market-surveillances-on-toy-safety/ND04o063-01_speelgoed.pdf

      (9)  Suortti T (1990) Determination of phenol in poly(vinyl chloride). J Chromatogr. 1990 May 16; 507:417-20. http://www.ncbi.nlm.nih.gov/pubmed/2380304

      (10)  CEN TC 52 (2002) Final report of the work of CEN/TC 52/WG 9 — Risk assessment. Contract BC/CEN/97/29.1.1. August 2002, p. 85.

      (11)  Scientific Committee on Health and Environmental Risks (SCHER), Opinion on ‘CEN's response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys’, adopted on 29 May 2007, pp. 8 and 9.

      (12)  European Food Safety Authority (EFSA), Scientific Opinion on the toxicological evaluation of phenol, EFSA Journal 2013;11(4):3189 [44 pp]. http://www.efsa.europa.eu/en/efsajournal/pub/3189.htm


Avis juridique important

|

31974L0562

Council Directive 74/562/EEC of 12 November 1974 on admission to the occupation of road passenger transport operator in national and international transport operations

Official Journal L 308 , 19/11/1974 P. 0023 - 0027 Finnish special edition: Chapter 7 Volume 1 P. 0160  Greek special edition: Chapter 07 Volume 1 P. 0236  Swedish special edition: Chapter 7 Volume 1 P. 0160  Spanish special edition: Chapter 07 Volume 2 P. 0025  Portuguese special edition Chapter 07 Volume 2 P. 0025

COUNCIL DIRECTIVE  of 12 November 1974  on admission to the occupation of road passenger transport operator in national and international transport operations  (74/562/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 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 the organization of the transport market is one of the essential factors in the implementation of the common transport policy provided for in the Treaty;  Whereas the adoption of measures aimed at coordinating the conditions of admission to the occupation of road passenger transport operator is likely to favour effective exercise of the right of establishment;  Whereas it is necessary to provide for the introduction of common rules for admission to the occupation of road passenger transport operator in national and international transport operations in order to ensure that road passenger transport operators are better qualified, thus contributing to rationalization of the market, improvement in the quality of the service provided in the interests of users, transport operators and the economy as a whole, and to greater road safety;  Whereas, therefore, the rules for admission to the occupation of road passenger transport operator should cover the good repute, financial standing and professional competence of operators;  Whereas, however, it is not necessary to include in these common rules certain kinds of transport which are of limited economic importance;  Whereas transitional measures must be introduced to enable Member States to adapt their national rules to those of the Community;  Whereas the harmonization of conditions for applying these common rules requires that provision be made for a Community consultation procedure as regards the appropriate national measures to be taken,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Admission to the occupation of road passenger transport operator shall be governed by the provisions adopted by the Member States in accordance with the common rules contained in this Directive.  2. For the purpose of this Directive, "the occupation of road passenger transport operator" means the activity of any natural person or any undertaking operating by means of motor vehicles so constructed and equipped as to be suitable for carrying more than nine persons - including the driver - and intended for that purpose, passenger transport services for the public or for specific categories of users against payment by the person transported or by the transport organizer.  For the purposes of this Directive, "undertaking" means any association or group of persons with or without legal personality, whether profit-making or not, or any official body, whether having its own legal personality or being dependent upon an authority having such personality.  3. Member States may, after consulting the Commission, exempt from the application of all or some of the provisions of this Directive natural persons or undertakings engaged exclusively in road passenger transport services for non-commercial purposes or having a main occupation other than that of road passenger transport operator, in so far as their transport operations have only a minor impact on the transport market.   Article 2 1. Natural persons or undertakings wishing to engage in the occupation of road passenger transport operator shall:    (a) be of good repute;       (b) be of appropriate financial standing;       (c) satisfy the condition as to professional competence.         Where the applicant is a natural person and does not satisfy provision (c), the competent authorities may  (1)OJ No C 17, 12.2.1969, p. 6. (2)OJ No C 26, 28.2.1969, p. 8.   nevertheless permit him to engage in the occupation of road passenger transport operator provided that he designates to the said authorities another person, satisfying provisions (a) and (c) above, who shall continuously and effectively manage the transport operations of the undertaking.  Where the applicant is an undertaking, provisions (a) and (c) above must be satisfied by one of the natural persons who will continuously and effectively manage the transport operations of the undertaking. Member States may also require that other persons in the undertaking satisfy provision (a) above.  2. Pending coordination at a later date, each Member State shall determine the provisions relating to good repute which must be satisfied by the applicant and, where appropriate, the natural persons referred to in paragraph 1.  3. Appropriate financial standing shall consist in having available sufficient financial resources to ensure the launching and proper administration of the undertaking. Pending coordination at a later date, each Member State shall determine what provisions and what methods of furnishing proof may be adopted for this purpose.  4. The condition as to professional competence shall consist in the possession of skills in the subjects listed in the Annex and recognized by the authority or body designated for that purpose by each Member State. The necessary knowledge shall be acquired by attending courses, by practical experience in a transport undertaking or by a combination of both. The Member States may exempt from the application of these provisions the holders of certain advanced diplomas or technical diplomas implying sound knowledge of the subjects listed in the Annex.  The production of a certificate issued by the authority or body referred to in the preceding subparagraph shall constitute proof of professional competence.   Article 3 1. Member States shall determine the circumstances in which operation of a road passenger transport undertaking may, by way of derogation from the provisions of Article 2 (1), be continued on a temporary basis for a maximum period of one year, with extension for a maximum period of six months, in duly justified special cases, in the event of the death or physical or legal incapacity of the natural person engaged in the occupation of transport operator or of the natural person who satisfies the provisions of Article 2 (1) (a) and (c).  2. However, the competent authorities in the Member States may, by way of exception and in certain special cases, definitively authorize a person not fulfilling the condition as to professional competence referred to in Article 2 (1) (c) to continue to operate the transport undertaking provided that such person possesses at least three years' practical experience in the day-to-day management of the undertaking.   Article 4 1. Natural persons and undertakings furnishing proof that before 1 January 1978, they were authorized under national regulations in a Member State to engage in the occupation of road passenger transport operator in national and/or international transport operations shall be exempt from the requirement to furnish proof that they satisfy the provisions laid down in Article 2.  2. However, those natural persons who, after 31 December 1974 and before 1 January 1978, were:    - authorized to engage in the occupation of road passenger transport operator without having furnished proof, under national regulations, of their professional competence, or       - designated continuously and effectively to manage the transport operations of the undertaking,         must satisfy, before 1 January 1980 the condition of professional competence referred to in Article 2 (4).  The same requirement shall apply in the case referred to in the third subparagraph of Article 2 (1).   Article 5 1. Decisions taken by the competent authorities of Member States pursuant to the measures adopted on the basis of this Directive and entailing the rejection of an application for admission to the occupation of road passenger transport operator shall state the grounds on which they are based.  2. Member States shall ensure that the competent authorities withdraw the authorization to pursue the occupation of passenger transport operator if they establish that the provisions of Article 2 (1) (a), (b) or (c) are no longer satisfied. In this case, however, they shall allow sufficient time for a substitute to be appointed.  3. With regard to the decisions referred to in paragraphs 1 and 2, Member States shall ensure that the natural persons or undertakings covered by this Directive are able to defend their interests by appropriate means.   Article 6 1. Member States shall, after consulting the Commission and before 1 January 1977, adopt the measures necessary for the implementation of this Directive, in particular Article 2 (4) thereof.  2. Member States shall ensure that the procedure for official verfication of the skills mentioned in  Article 2 (4) shall become operative for the first time before 1 January 1978.   Article 7 This Directive is addressed to the Member States.     Done at Brussels, 12 November 1974.  For the Council  The President  J. SAUVAGNARGUES     ANNEX LIST OF SUBJECTS REFERRED TO IN ARTICLE 2 (4)   The knowledge to be taken into consideration for the official recognition of professional competence must cover at least the subjects listed below. These must be described in full detail and have been worked out or approved by the competent national authorities. They must be so designed as to be within the grasp of those persons whose education corresponds to the level normally reached at school-leaving age.    A. SUBJECTS OF WHICH KNOWLEDGE IS REQUIRED FOR TRANSPORT OPERATORS INTENDING TO ENGAGE EXCLUSIVELY IN NATIONAL TRANSPORT OPERATIONS      1. Law  Elements of civil, commercial, social and fiscal law, as necessary for engaging in the occupation, with particular emphasis on:        - general contracts;               - transport contracts, with particular reference to the responsibility of the transport operator (nature and limits);               - commercial companies;               - ledgers;               - regulations governing labour, social security;               - taxation systems.                          2. Business and financial management of an undertaking        - methods of payment and financing;               - costing;               - system of fares, prices and conditions of transport;               - business accounts;               - insurance;               - invoices;               - travel agencies.                          3. Regulation of road passenger services        - institution of transport services and transport plans;               - conditions of fulfilment of passenger services;               - provisions relating to admission to and pursuit of the occupation;               - transport documents.                          4. Technical standards and aspects of operation        - vehicle selection;               - type-approval and registration;               - vehicle maintenance standards.                          5. Road safety      - laws, regulations and administrative provisions applicable to traffic;           - traffic safety;           - geographical knowledge of routes;           - accident prevention and procedure in the event of an accident.                   B. SUBJECTS OF WHICH KNOWLEDGE IS REQUIRED FOR TRANSPORT OPERATORS INTENDING TO ENGAGE IN INTERNATIONAL TRANSPORT    - subjects listed under A;       - provisions applicable to passenger transport by road between Member States and between the Community and non-member countries, arising out of national laws, Community standards, international conventions and agreements;       - practice and formalities connected with border-crossings;       - main traffic regulations in the Member States.