1976L0895 — EN — 21.03.2007 — 026.001

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►B COUNCIL DIRECTIVE of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (76/895/EEC) (OJ L 340, 9.12.1976, p.26)

Amended by:





Amended by:





Corrected by:









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COUNCIL DIRECTIVE

of 23 November 1976

relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables

(76/895/EEC)







THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament ( 1 ), Having regard to the opinion of the Economic and Social Committee ( 2 ), Whereas crop production plays an important role in the European Economic Community; Whereas the yield from that production is continually affected by harmful organisms of either animal or vegetable origin and also by viruses; Whereas it is absolutely essential to protect plants against these organisms, not only to prevent a reduction in yield but also to increase agricultural productivity; Whereas one of the most important methods of protecting plants and plant products from the effect of these harmful organisms is by the use of chemical pesticides; Whereas, however, these pesticides do not have only a favourable effect on plant production, since they are generally toxic substances or preparations with dangerous side effects; Whereas a large number of these pesticides and of their metabolized or breakdown products may have harmful effects on consumers of plant products; Whereas these pesticides should not be used in circumstances which could present a risk to human or animal life; Whereas different methods exist in certain Member States for avoiding this risk; whereas some of these States have fixed different levels for the maximum content of the residues of certain pesticides in or on treated plants and plant products which must be observed when these products are put into circulation; Whereas the differences which exist between Member States for the maximum permissible levels for pesticide residues can help to create barriers to trade and thus hinder the free movement of goods within the Community; whereas for this reason certain maximum levels should be fixed which may be applied by the Member States; Whereas in fixing these maximum levels the requirements of plant production and the need to protect human and animal health must be reconciled; Whereas, initially, maximum levels should be fixed for the residues of certain pesticides in and on fruit and vegetables taking into account the fact that fruit and vegetables are generally intended for human consumption and, on occasions, for animal feed; whereas these maximum levels must represent the lowest possible levels; Whereas the free circulation throughout the Community of products with a level of residue of certain pesticides less than or equal to the maxima fixed in Annex II should be assured; whereas at the same time Member States should be allowed to permit the circulation in their territory, without discrimination and in cases where they consider this justified, of products which have a content higher than the said maxima either by fixing or by refraining from fixing maximum levels for them; Whereas it is not necessary to apply the provisions of this Directive to fruit and vegetables intended for export to third countries; Whereas, nevertheless, the maximum levels fixed in Annex II could unexpectedly prove dangerous to human or animal health; whereas Member States should therefore be allowed in that case to reduce temporarily these levels; Whereas it is appropriate in that case to establish close cooperation between the Member States and the Commission within a Standing Committee on Plant Protection; Whereas, where Member States fix maximum content levels for products marketed on their territory they should make certain that these levels are observed by means of official checks, consisting, at least, of sampling; Whereas, in that case, the official checks should be made by using Community methods of sample-taking and Community methods of analysis; Whereas the fixing of methods of sampling and analysis is a technical and scientific implementing measure; whereas in order to facilitate the adoption thereof, the rules relating to those samples and analyses should be laid down by means of a procedure establishing close cooperation between the Member States and the Commission within the Standing Committee on Plant Protection; Whereas any amendment to the Annexes should, in view of their basically technical nature, be made easier by an accelerated procedure, HAS ADOPTED THIS DIRECTIVE:







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Article 1

1. This Directive concerns products intended for human or, in exceptional cases, animal consumption listed under the Common Customs Tariff headings set out in Annex I and in or on which are found the pesticide residues listed in Annex II.

2. This Directive shall also apply to the same products after drying or processing or after inclusion in a composite food in so far as they may contain certain pesticide residues.

3. This Directive shall apply without prejudice to Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae ( 3 ) and Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children ( 4 ). However, until maximum levels have been established in accordance with the provisions of Article 6 of Directive 91/321/EEC or Article 6 of Directive 96/5/EC the provisions of Article 5a (1) and (3) to (6) of this Directive shall apply for the products concerned.

Article 2

For the purposes of this Directive:

1. ‘pesticide residues’ shall mean residues of the pesticides and of their metabolites, and breakdown or reaction products as defined in Annex II, which are present in or on the products referred to in Article 1;

2. ‘putting into circulation’ shall mean any post-harvest handing over, whether or not for a consideration, of the products referred to in Article 1.

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Article 3

1. Member States may not prohibit or impede the putting on the market within their territories of the products referred to in Article 1 on the ground that they contain pesticide residues if the quantity of these residues does not exceed the maximum levels laid down in Annex II.

2. Member States may, in cases where they consider this justified, authorize the circulation within their territories of products referred to in Article 1 which contain pesticide residues higher than those laid down in Annex II.

3. Member States shall inform the other Member States and the Commission of any implementation of paragraphs 1 and 2.

Article 4

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1. Where a Member State, as a result of new information or of a reassessment of existing information considers that a maximum level fixed in Annex II endangers human or animal health, and therefore requires swift action to be taken, that Member State may temporarily reduce the level in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures taken, attaching a statement of the reasons therefor.

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2. In accordance with the products laid down in Article 8, it shall be decided whether the maximum levels laid down in Annex II are to be amended. Until such time as a decision is taken by the Council or the Commission in accordance with the abovementioned procedure, the Member State may maintain the measures which it has implemented.

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Article 5

Amendments to Annexes I and II as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 7. In particular, when establishing maximum residue levels, account shall be taken of a relevant dietary intake risk assessment and of the number and quality of the data available.

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Article 5a

1. For the purposes of this Article a Member State of origin shall be defined as the Member State in whose territory a product specified in Article 1 (1) and (2) is either legally produced and marketed or put into free circulation, and a Member State of destination as the Member State into whose territory such product is introduced and put into circulation for operations other than transit to another Member State or third country.

2. Member States shall introduce arrangements for establishing maximum residue levels, whether permanent or temporary, for products referred to in Article 1 (1) and (2), brought into their territories from a Member State of origin, taking into account good agricultural practice in the Member State of origin, and without prejudice to conditions necessary to protect the health of consumers, in cases where no maximum residue levels have been established for these products in accordance with Article 5.

3. Where

— no maximum residue level has been established for a product referred to in Article 1 (1) and (2) in accordance with Article 5, and

— that product, which satisfies the maximum residue levels applied by its Member State of origin, has been subjected in the Member State of destination to measures whose effect is to prohibit or restrict its putting into circulation, on the grounds that the product contains pesticide residue levels in excess of the maximum residue level accepted in the Member State of destination, and

— either the Member State of destination has introduced new maximum residue levels or has altered the levels laid down in its legislation, or it has made changes to its controls which are disproportionate and/or discriminatory compared with those for its domestic production, or the maximum residue level applied by the Member State of destination differs substantially from the corresponding levels established by other Member States, or the maximum residue level applied by the Member State of destination represents a disproportionate level of protection compared with the level of protection applied by the Member State to pesticides carrying a similar risk or to similar agricultural products or foodstuffs,

the following exceptional provisions shall apply:

(a) the Member State of destination shall communicate the measures adopted to the other Member State concerned and the Commission within 20 days of their application. The notification shall document the facts involved;

(b) on the basis of the notification referred to in (a), the two Member States concerned shall contact each other without delay in order to remove, whenever possible, the prohibitive or restrictive effect of the measures adopted by the Member State of destination by means of measures agreed between them; the Member States shall submit all the requisite information to each other. Within a period of three months of the notification referred to in (a), the Member States concerned shall inform the Commission of the result of such contacts and in particular the measures they intend to apply, if any, including the maximum residue level they have agreed. The Member State of origin shall inform the other Member States of the result of such contacts;

(c) the Commission shall immediately refer the matter to the Standing Committee on Plant Health and, if possible, submit a proposal aimed at establishing in Annex II a temporary maximum residue level, which shall be adopted in accordance with the procedure laid down in Article 7. In its proposal, the Commission shall take account of existing technical and scientific knowledge on the matter and in particular data submitted by the Member States with an interest, especially the toxicological assessment and estimated ADI, good agricultural practice and the trial data which the Member State of origin used to establish the maximum residue level, together with the reasons given by the Member State of destination for deciding on the measures in question. The period of validity of the temporary maximum level shall be laid down in the legal act adopted and may not exceed four years. That period may be linked to the supply, by the Member State of origin and/or other Member States with an interest, of the trial data required by the Commission in order to set the maximum residue level in accordance with Article 5. At their request, the Commission and the Member States shall be kept informed regarding the programme of trials established.

4. Any measure provided for in paragraphs 2 or 3 shall be taken by a Member State with due regard for its obligations under the Treaty, in particular Articles 30 to 36 thereof.

5. Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations ( 5 ) shall not apply to measures adopted and notified by Member States in accordance with paragraph 3 of this Article.

6. Detailed measures for the implementation of the procedure set out in this Article may be adopted in accordance with the procedure laid down in Article 8.

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Article 6

1. Member States shall take all necessary measures to ensure compliance with any maximum levels laid down in accordance with this Directive by carrying out random checks.

2. Member States shall take all necessary measures to ensure that, where the products referred to in Article 1 are subject to the verification provided for in paragraph 1, the sampling and qualitative and quantitative analysis carried out for the purposes of identifying and estimating the amounts of pesticide residues shall be carried out according to the processes and methods to be laid down in accordance with the procedure provided for in Article 7.

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Article 7

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002 ( 6 ).

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC ( 7 ) 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 8

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this Article, 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 fifteen days.

Article 8a

1. The Commission shall be assisted by a committee.

2. Where reference is made to this Article, 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.

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Article 9

1. This Directive shall apply to products referred to in Article 1 intended for export to third countries. However, maximum pesticide residue levels set in accordance with this Directive shall not apply in the case of products treated before export where it can be satisfactorily proved that:

(a) the third country of destination requires a particular treatment in order to prevent the introduction of harmful organisms into its territory; or

(b) the treatment is necessary in order to protect the products against harmful organisms during transport to the third country of destination and storage there.

2. This Directive shall not apply to the products referred to in Article 1 where it can be satisfactorily proved that they are intended for:

(a) the manufacture of products other than foodstuffs or animal feed; or

(b) sowing or planting.

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Article 10

This Directive shall apply without prejudice to Community provisions concerning common quality standards for fruit and vegetables.

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Article 10a

Member States shall bring into force the laws, regulations and administrative provisions necessary to ensure that the amendments in Annex II resulting from Decisions referred to in Article 5 can be implemented in their territory within a maximum period of eight months from their adoption, and within a shorter implementation period when required for urgent reasons of human health protection.

In order to safeguard legitimate expectations, Community legal implementing acts may provide for transitional periods for the implementation of certain maximum residue levels allowing the normal marketing of the harvested products.

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Article 11

Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive within a period of two years following its notification and shall forthwith inform the Commission thereof.

Article 12

This Directive is addressed to the Member States.









ANNEX I







List of products referred to in Article 1 CCT heading No Description 07.01 B Cabbages, cauliflowers and Brussels sprouts, fresh or chilled 07.01 C Spinach, fresh or chilled 07.01 D Salad vegetables, including endive and chicory, fresh or chilled 07.01 E Chard (or white beet) and cardoons, fresh or chilled 07.01 F Leguminous vegetables, shelled or unshelled, fresh or chilled 07.01 G Carrots, turnips, salad beetroot, salsify, celeriac, radishes and similar edible roots, fresh or chilled 07.01 H Onions, shallots and garlic, fresh or chilled 07.01 IJ Leeks and other alliaceous plants, fresh or chilled 07.01 K Asparagus, fresh or chilled 07.01 L Artichokes, fresh or chilled 07.01 M Tomatoes, fresh or chilled 07.01 N Olives, fresh or chilled 07.01 O Capers, fresh or chilled 07.01 P Cucumbers and gherkins, fresh or chilled 07.01 Q Mushrooms and truffels, fresh or chilled 07.01 R Fennel, fresh or chilled 07.01 S Sweet peppers, fresh or chilled 07.01 T Other, fresh or chilled ex 07.02 Vegetables, uncooked, frozen ex 08.01 Dates, bananas, coconuts, Brazil nuts, cashew nuts (1), avocados, mangoes, guavas and mangosteens, fresh, shelled or peeled ex 08.02 Citrus fruit, fresh (1) ex 08.03 Figs, fresh (1) ex 08.04 Grapes, fresh (1) ex 08.05 Nuts, other than those falling within heading No 08.01, fresh (1), shelled or peeled 08.06 Apples, pears and quinces, fresh (1) 08.07 Stone fruit, fresh (1) 08.08 Berries, fresh (1) 08.09 Other fruit, fresh (1) ex. 08.10 Fruit, uncooked, preserved by freezing, not containing added sugar (1) (1) Chilled fruit is treated in the same way as fresh fruit.









ANNEX II







List of pesticide residues and maximum residual levels ►M3 EEC No (1) ◄ Pesticides Maximum levels (in mg/kg (ppm)) Common name Chemical formula ▼M7 ————— ▼M3 ————— ▼M7 ————— ▼M12 ————— ▼B ►M3 15/42 ◄ ►M3 azinphos-methyl ◄ 0,0-dimethyl-S-[4-oxo-3H-1,2,3-benzo-triazine-3-yl)-methyl]-dithiophosphate ►M3 1: grapes, citrus fruit 0·5: other products ◄ ►M3 6/20 ◄ ►M19 ◄ ►M19 4-chlorobut-2-ynyl 3-chlorocarbanilate; isopropyl 3-chlorophenylcarbamate; 1-methylprop-2-ynyl-3-chlorophenylcarbamate ◄ ►M3 0·1: celery, carrots, chervil, parsnip, parsley 0·05: other products ◄ ▼M7 ————— ▼M22 ————— ▼M20 ————— ▼M7 ————— ▼M3 ————— ▼M10 ————— ▼M14 ————— ▼B ►M3 6/19 ◄ ►M3



►M10 triallate: ◄ sum ►M10 triallate ◄ ◄ ►M3 S-2,3-dichloroallyl di-isopropylthiocarbamate; S-2,3,3-trichloroallyl di-isopropylthiocarbamate ◄ ►M3 0·1 ◄ ▼M7 ————— ▼M14 ————— ▼M7 ————— ▼B ►M3 — ◄ dodine N-dodecylguanidine acetate ►M5 1: pome and stone fruit 0·2: other products ◄ ►M3 602/33 ◄ ►M3 endosulphan (sum of α- and β-endosulphan and endosulphan sulphate) ◄ 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a,-hexahydro-6,9-methano-2,3,4-benzo(e)-dioxathiepin-3-oxide ►M8 ◄ ▼M7 ————— ▼M20 ————— ▼M14 ————— ▼M7 ————— ▼M13 ————— ▼B ►M3 15/44 ◄ malathion S[-1,2-bis (ethoxy-carbonyl)-ethyl]-0,0-dimethyl-dithiophosphate ►M5 2: citrus fruit 3: vegetables, except root vegetables 0·5: other products ◄ including malaoxon S-(-1,2-bis (ethoxy-carbonyl)-ethyl)-0,0-dimethyl-thiophosphate ▼M10 ————— ▼M13 ————— ▼B paraoxon 0,0-diethyl-0-(4-nitro-phenyl)-phosphate 0·5 ▼M18 ————— ▼M23 ————— ▼M22 ————— ▼B ►M3 — ◄ propoxur 2-iso propoxy phenyl methylcarbamate ►M8 3·0 ◄ ▼M7 ————— ▼B ►M3 6/5 ◄ thiram bis (dimethyl-thio-carbamoyl)-disulphide 3·8: strawberries, grapes 3·0: other products ▼M7 ————— ▼B ►M3 15/21 ◄ trichlorfon 0,0-dimethyl-(2,2,2-trichloro-1-hydroxy-ethyl)-phosphonate 0·5 ▼M7 ————— ▼M15 ————— ▼M7 ————— ▼M21 ————— ▼M3 chlormequat, expressed as chlormequat cation 2-chloroethyltrimethyl ammonium ion ►M8 ◄ ▼M7 ————— ▼M8 ————— ▼M3 dichlofluanid N-dichlorofluoromethylthio-N,N'-dimethyl-N-phenylsulphamide 10: lettuce, strawberries, other berries, grapes 5: other products ▼M22 ————— ▼M8 ————— ▼M7 ————— ▼M17 ————— ▼M8 ————— ▼M7 ————— ▼M3 methyl bromide bromomethane ►M7 0,1: nuts, apricots, peaches, plums, figs and grapes ◄ ▼M7 ————— ▼M3 pyrethrins (sum of pyrethrins I and II, cinerins I and II, jasmolins I and II) — 1 vamidothion (sum of vamidothion and vamidothion sulphoxide) 0,0-dimethyl S-2-(1-methylcarbamoylethylthio) ethyl phosphorothioate 0·5: pome fruit 0·05: other products chinomethionat 6-methyl-1,3-dithiolo [4,5-b] quinoxalin-2-one 0·3 ▼M22 ————— ▼M7 ————— ▼M23 ————— ▼M5 phosalone S-(6-chloro-2-oxobenzo-oxazolin-3-yl) methyl 00-diethyl phosphorodithioate 1: citrus fruit and strawberries 2: pome fruit and peaches 0·1: root vegetables and olives 1: other products ▼M7 ————— (1) Numbering of Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ No 196, 16. 8. 1967, p. 5), as last amended by Directive 75/409/EEC (OJ No L 183, 14. 7. 1975, p. 22). (2) Negligible residues below the lower limit of sensitivity under the method of determination are tolerated. (3) Possibly including the maximum level of 0·4 ppm fixed for omethoate.