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CA-Sept09-Doc.3.4a WORKING DOCUMENT: DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate B - Protecting the Natural Environment ENV.B.3 - Biotechnology, Pesticides and Health 34th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market Establishment of maximum residue levels for residues of active substances contained in biocidal products Introduction 1) Article 10(2)ii(b) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market 1 lays down that, where relevant, maximum residue levels (MRLs) should be established. 2) However, unlike other legal frameworks, such as those for both veterinary medicinal products and plant protection products, no other specific Community legal instrument was developed detailing the rules for the establishment of MRLs for active substances used as biocides. 3) In addition, residues of biocidal products that could be present in food and feed do respond to the definition of contaminants, as provided under Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food 2 . 1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market OJ L 123 , 24/04/1998, p. 1 2 OJ L 37, 13/02/1993, p. 1 Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. Office: BU9 6/124. Telephone: direct line (32-2) 298 69 33. Fax: (32-2) 299 85 58. E-mail: [email protected]

Transcript of · Web viewEUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate B - Protecting the...

CA-Sept09-Doc.3.4a

WORKING DOCUMENT: DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSIONEUROPEAN COMMISSIONDIRECTORATE-GENERALENVIRONMENTDirectorate B - Protecting the Natural EnvironmentENV.B.3 - Biotechnology, Pesticides and Health

34th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on

the market

Establishment of maximum residue levels for residues of active substances contained in biocidal products

Introduction

1) Article 10(2)ii(b) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market1 lays down that, where relevant, maximum residue levels (MRLs) should be established.

2) However, unlike other legal frameworks, such as those for both veterinary medicinal products and plant protection products, no other specific Community legal instrument was developed detailing the rules for the establishment of MRLs for active substances used as biocides.

3) In addition, residues of biocidal products that could be present in food and feed do respond to the definition of contaminants, as provided under Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food2.

4) This Regulation defines a 'contaminant' as any substance not intentionally added to food which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination.

5) Regulation (EEC) No 315/93 also provides that, where necessary, in order to protect public health, maximum tolerances for specific contaminants shall be established, except for contaminants subject of more specific Community rules, such as substances used in pesticides or veterinary medicinal products.

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market OJ L 123 , 24/04/1998, p. 1

2 OJ L 37, 13/02/1993, p. 1

Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11.Office: BU9 6/124. Telephone: direct line (32-2) 298 69 33. Fax: (32-2) 299 85 58.

E-mail: [email protected]

6) Against that complex legal background, it is however expected that, among the 270 existing substances remaining to be evaluated in the framework of the 10-year review programme under the Biocides Directive, as well as for new active substances, very few are likely to leave residues in food or feed under normal conditions of uses.

7) It is in addition expected that these substances will be used in products belonging to the following categories of product-type (PT), as listed in Annex V of the Directive:

PT3: Veterinary hygiene biocidal productsPT4: Food and feed area disinfectantsPT5: Drinking water disinfectantsPT18: InsecticidesPT19: RepellentsPT20: Preservatives for food and feedstocks3

General principles of food law

8) Regulation (EC) No 178/20024 laying down the general principles and requirements of food law establishes that food must not be placed on the market if it is unsafe, i.e. if it is harmful to health and/or unfit for consumption. In determining whether any food is unsafe, account is taken of the normal conditions of use, the information provided to the consumer, the likely immediate or delayed effect on health, the cumulative toxic effects and, where appropriate, the particular health sensitivities of a specific category of consumers.

9) In accordance with Article 14 of that Regulation, if food which is unsafe forms part of a batch, lot or consignment, the entire quantity is presumed to be unsafe.

10) Similarly, in accordance with Article 15 of that Regulation, feed must not be placed on the market or given to any food-producing animal if it is unsafe. Feed is deemed to be unsafe if it has an adverse effect on human or animal health. The entire quantity of a batch, lot or consignment is considered unsafe if any part of it fails to satisfy the requirements.

11) At all stages of the food production chain, business operators must ensure that food and feed satisfies the requirements of food law and that those requirements are being adhered to. The Member States enforce the law, ensuring that operators comply with it and laying down appropriate measures and penalties for infringements.

12) The traceability of food, feed, food-producing animals and all substances incorporated into foodstuffs must be established at all stages of production, processing and distribution. To this end, business operators are required to apply appropriate systems and procedures.

3 Most of these products fall within the scope of Directive 95/2/EC on food additives other than colours and sweeteners or of Regulation (EC) No 1831/2003 on additives for use in animal nutrition and are therefore excluded them from the scope of Directive 98/8/EC

4 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L31, 1/2/2002, p.1.

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13) If an operator considers that a food or feed product which has been imported, produced, processed, manufactured or distributed is harmful to human or animal health, steps must be taken immediately to withdraw the product from the market and to inform the competent authorities accordingly. In cases where a product may have reached consumers, the operator must inform them and recall the products already supplied.

Recent developments

14) For substances used in biocidal products, Article 10(2)ii(b) of Directive 98/8/EC lays down that, where relevant, maximum residue levels (MRLs) should be established. However, unlike for veterinary medicinal products and plant protection products, no other specific Community legal instrument was developed detailing the rules for the establishment of MRLs for active substances used as biocides.

15) In the general context of better regulation and simplification, the Commission considered it unnecessary to develop a new piece of legislation, when the matter could be adequately addressed by existing legal instruments. Besides, if a separate legal framework had been developed for biocides, one would have run the risk of a substance ending up with different MRLs, as it already happened with substances used in both veterinary medicinal products and plant protection products.

16) The Commission therefore used the opportunity of the revision of Regulation 2377/905 to propose that the scope of the new regulation on the establishment of maximum residue limits for pharmacologically active substances in foodstuffs of animal origin also covers pharmacologically active substances contained in biocidal products used in animal husbandry.

17) The main rationale for applying a similar approach for residues of biocidal products and for those of veterinary medicinal products was twofold: first, from the control authorities point of view what matters is not so much the origin of the residue as its level; second, from the scientific point of view, the methodology to be followed is expected to be broadly similar.

18) This has now been accepted and Article 10 of Regulation EC No 470/2009, which replaces Regulation 2377/90, provides a mechanism for the setting up of MRLs for substances used in biocidal products in animal husbandry. This will cover products such as veterinary hygiene biocidal products (PT3), insecticides (PT18) and repellents (PT19).

19) Discussions have now started with the EMEA, which will be responsible for issuing scientific opinions on MRLs for pharmacologically active substances used or intended to be used in biocidal products used in animal husbandry. The details of the process and responsibilities will be established in co-operation between the Commission, the EMEA and a working group representing the MS Competent Authorities for biocides.

20) The Commission will now take the necessary steps to clarify the process for the establishment of MRLs for substances which may lead to the presence of

5 Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin. OJ L 224, 18.8.1990

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residues in other circumstances than their use in animal husbandry. This process is expected to rely on Regulation 396/2005 and on the scientific input of EFSA.

21) Lastly, in the context of the revision of Directive 98/8/EC, the Commission has proposed a new wording to Article 10(2)ii(b), stating that where appropriate, maximum residue limits shall be established, with respect to active substances included in Annex I, in accordance with Regulation 396/2005 or Regulation 470/2009.

Maximum residue limits (MRLs)

22) Pursuant to Article 3(c) of Regulation 396/2005, the maximum limits set by that Regulation apply to residues of active substances which may arise as a result of use as a biocide, provided that the active substance is currently or formerly used in plant protection products.

23) Pursuant to Article(1)(1)(a) of Regulation 470/2009, the maximum limits established pursuant to that Regulation apply to pharmacologically active substance, regardless of the use from which the residue results.

24) If specific MRLs have been established under Regulations 396/20056 or 470/2009, then these are already today applicable to residues of substances used in biocidal products.

25) If no specific MRLs have been established, then the default value of 0,01 mg/kg set out in Regulation 396/2005 is applicable for residues of substances, which are also currently or were used in plant protection products7.

26) The MRLs set under Regulation 396/2005 apply to a wide range of commodities (see Annex II) as well as to processed products (e.g. oil, wine, juices, etc) or composite products (e.g. pizzas, ketchup, corn flakes, etc).

27) The residues of 83 of the 145 substances included in the review programme for PT 3, 4, 5, 18, 19 and 20 are thus already covered by specific or default MRLs, since they either have MRLs established under Regulation 396/2005, are currently or formerly used in plant protection products, or have MRLs laid down in one of the annexes to Regulation 2377/90, which are still applicable pursuant to Article 29 of Regulation 470/2009 (see Annex I to this note for details).

28) However, among the 62 remaining substances, not all of them will be used in a context, where they might lead to the presence of residues.

29) If they lead to the presence of residues and if it is necessary to establish MRLs, this would be done, depending on the area of use, via Regulation

6 MRLs set for crops and pesticides can be found in the MRL database on the Commission website at http://ec.europa.eu/sanco_pesticides/public/index.cfm

7 In accordance with Article 18(1)(b) of Regulation 396/2005, the products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding: (a) the MRLs for those products set out in Annexes II and III; (b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance in accordance with the procedure referred to in Article 45(2) while taking into account the routine analytical methods available. Such default values shall be listed in Annex V.

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396/2005 or Regulation 470/2009. For Regulation 396/2005, it would however require an amendment of the current text to enlarge its scope to residues of substances used in biocidal products only.

30) Also, for MRLs of active substances currently or formerly used for plant protection, the applicant/authorisation holder could where necessary apply for the establishment of MRLs, less penalising than the default value of 0,01 mg/kg. This would however also require the same amendment of Regulation 396/2005 as indicated above.

31) Lastly, if residues are found in food or feed and that no MRLs, either specific or default, have been established, then Articles 14 and 15 of the General Food Law would apply and the food or the feed could be declared unsafe after an ad hoc risk assessment.

32) In specific cases, the Commission services could also rely on the provisions of Regulation (EEC) No 315/93 on contaminants and set up specific limits for the residues of certain substances.

33) Commission Regulation (EC) 1881/20068 already sets limits for:

mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, T2 and HT-2-toxin)

metals (cadmium, lead, mercury and inorganic tin) dioxins and dioxin-like PCBs 3-MCPD polycyclic aromatic hydrocarbons (benz(o)pyrene).

Authorisation of biocidal products

34) For products containing active substances that may lead to residues in food or feed, Member States shall ensure that products are only authorised if these residues have no unacceptable effects on human health, in accordance with Article 5(1)(b)(iii) of Directive 98/8/EC.

35) Competent Authorities for Biocidal Products, when granting authorisations for products that may leave residues into food or feed would however not be expected to set MRLs but should ensure that the directions for use of the product contain inter alia appropriate directions to prevent animals or plants from being unnecessarily exposed to the active substance or to relevant degradation products (e.g. 'Do not use in the presence of the animals', 'Animals shall not re-enter the room before 24 hours after the end of the application of the product') or to remove food before treatment (e.g. 'Do not use in the presence of food commodities'). Other measures might be added to ensure that the level of residues tolerated in food shall not be exceeded.

36) These measures will be derived from the risk assessment and will take into account the conditions of use of the product.

8 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs .  OJ L 364, 20.12.2006, p. 5–24

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37) Applicants will therefore need to submit residues data to allow competent authorities to perform this risk assessment. However, as it can realistically not be expected that residue data will be available for each and every food commodity, the absence of an exhaustive data set could be compensated by taking a conservative approach in the risk assessment.

38) Finally, Annex I inclusions for substances that may lead to the presence of residues in food will contain a specific provision stating that:

39) For products containing substance X that may lead to residues in food, Member States shall ensure that labels and/or safety data sheets must contain instructions for use, such as the adherence to waiting periods, which ensure that MRLs set out in Regulation (EC) No 396/2005 of the European Parliament and of the Council(*) or, as appropriate, established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (**) are not exceeded.

Enforcement and controls

40) Food business operators are responsible for food safety, which includes compliance with MRLs. Member State authorities are responsible for control and enforcement of the MRLs. To ensure that this is done in an adequate and uniform way, the Commission relies on several instruments:

41) In the veterinary sector, Council Directive 96/23/EC9 on measures to monitor certain substances and residues thereof in live animals and animal products establishes that Member States should draft a national residue monitoring plan for the groups of substances detailed in Annex I. These plans must comply with the sampling rules in Annex IV to the Directive.

42) Directive 96/23/EC establishes the frequencies and level of sampling and the groups of substances to be controlled for each food commodity. Commission Decision 97/747/EC10 provides further rules for certain animal products: milk, eggs, honey, rabbits and game meat. Commission Decision 98/179/EC11 of 23 February 1998 lays down detailed rules for official sampling procedures and official treatment of samples until they reach the laboratory responsible for analysis.

43) In the plant protection sector, the co-ordinated EU multi-annual control programme12 established by Regulation (EC) No 396/2005 sets out for each Member State the main pesticide-crop combinations to monitor and the minimum numbers of samples to take. Member States have to report the results, which are published in an annual report.

44) Community Reference Laboratories13 co-ordinate, train staff, develop methods of analysis and organise tests to evaluate the skills of the different national control laboratories.

9 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996L0023:EN:NOT10 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997D0747:EN:NOT11 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998D0179:EN:NOT12 http://ec.europa.eu/food/plant/protection/pesticides/multi-annual_control_programmes_en.htm13 http://www.crl-pesticides.eu/

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45) The Food and Veterinary Office14 of the Commission carries out inspections in the Member States to assess and audit their control activities.

46) If residues of pesticides or of veterinary medicinal products are found at a level of concern for consumers, the Rapid Alert System for Food and Feed15

(RASFF) circulates the information and measures are taken to protect the consumer

47) In any event, control authorities when monitoring the presence of residues would refer themselves to Regulations 396/2005 and 470/2009.

14 http://ec.europa.eu/food/fvo/index_en.htm15 http://ec.europa.eu/food/food/rapidalert/index_en.htm

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Annex I

Substances included in the review programme for PT 3, 4, 5, 19 or 20

common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

2-Butanone, peroxide x

2-chloroacetamide x

2-Phenoxyethanol x x

Abamectin x x Annex I x

Acetamiprid x x x

Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ

x x x

ADBAC x x x x

ADBAS x x x

Akacid x x x x

Akacid forte x x x x

alpha-Cypermethrin x x Annex I x

Aluminium Phosphide x x x x

Ampholyt 20 x x

Azamethiphos x x Annex I, II, III x

Bacillus sphaericus strain 2362 x x x

Bacillus subtilis x x x

Bardap 26 x

Bendiocarb x x x

Benzoic acid x x x Annex II (E210) x

Biphenyl-2-ol x x

BKC x x x Annex II x

Bromoacetic acid x

BTI strain AM65-52 x x x

BTI strain SA3A x x x

Calcium dihydroxide / calcium hydroxide / caustic lime / hydrated lime / slaked lime

x x Annex IIx

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common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

Calcium hypochlorite x x x

Calcium magnesium oxide / dolomitic lime x

Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime

x

Calcium oxide / lime / burnt lime / quicklime x x Annex II x

Carbon dioxide x x x Annex II (E290) x

CHDG x

Chlorfenapyr x x x

Chlorine x

Chlorine dioxide x x x

Chlorocresol x Annex II

Chlorophene x

Chrysanthemum cinerariaefolium, ext. x Annex II

Cis-tricos-9-ene x

Citriodiol x

Clothianidin x x x

Copper x x

Copper sulphate x x

Cyanamide x x x x

Cyclopropanecarboxylic acid, 3-[(xZ)-2-chloro-3,3,3-trifluoro-x-propenyl]-2,2-dimethyl-, (2-methyl[x,x’-biphenyl]-3-ylmethyl ester, (xR,3R)-rel- / Bifenthrin / Biphenate

x

x

Cyfluthrin x x Annex I x

Cypermethrin x x Annex I x

Cyphenothrin x

Cyromazine x x Annex I x

d-Allethrin x x

DBNPA x

DCPP x

DDAC 2 2 x x

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common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

Decanoic acid x x x x

DEET x x x

Deltamethrin x x Annex I x

Diamine x x

Dichlorvos x x x

Diflubenzuron x x Annex I x

Disodium peroxodisulphate / Sodium persulphate x

d-Phenothrin x x

d-Tetramethrin x

Empenthrin x

Esbiothrin x x

Esfenvalerate x x x

Ethanol x x Annex II x

Etofenprox x x x

Fipronil x x x

Flufenoxuron x x x

Formaldehyde x x x x Annex II x

Formic acid x x x x Annex II x

Geraniol x x

Glucoprotamin x

Glutaraldehyde x x x Annex II

Glycollic acid x x

Glyoxal x x x

Hexaflumuron x x x

Hydrogen cyanide x x

Hydrogen peroxide x x x x Annex II x

Icaridine x

Imazalil x x x

Imidacloprid x x x

Imiprothrin x

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common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

Iodine x Annex II

IR3535 x

L-(+)-lactic acid x x x Annex II x

Lambda cyhalothrin x x x

Lauric acid x x

Lavender, Lavandula hybrida, ext. / Lavandin oil x

Magnesium Phosphide x x x x

Margosa extract x x

Methylneodecanamide / MNDA22 x

Methynonylketone x x

Mixture of CMIT/MIT x

Naled x x x

Nitrogen x x x

Nonanoic acid x

Octanoic acid x x x

PAP x x

Pentapotassium bis(peroxymonosulphate) bis(sulphate) x x x

Peracetic acid x x x x Annex I x

Perestane x

Permethrin x x Annex I x

Peroxyoctanoic acid x x

PHMB x x x

Piperonyl butoxide / PBO x x Annex II x

Poly(hexamethylenebiguanide) x x

Polymer of formaldehyde and acrolein x

Prallethrin x

Propan-1-ol x

Propan-2-ol x

PVP-iodine (see iodine) x Annex II

Pyrethrins and Pyrethroids x x x x

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common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

Pyriproxyfen x x x

Quaternary ammonium compounds, benzyl-Cx2-x4-alkyldimethyl, chlorides (see ADBAC)

x x xx

Quaternary ammonium compounds, benzyl-Cx2-x8-alkyldimethyl, chlorides (see ADBAC)

x x xx

Quaternary ammonium compounds, Cx2-x4-alkyl[(ethylphenyl)methyl]dimethyl, chlorides (see ADBAC)

x x xx

Quaternary ammonium compounds, di-C8-x0-alkyldimethyl, chlorides (see DDAC)

x x x xx

Salicylic acid x x x

Silicium dioxide / Kieselguhr x Annex II (E551) x

Silicon dioxide – amorphous x x Annex II (E552)

Silver x x

Silver chloride x x x

Silver sodium hydrogen zirconium phosphate x

Silver zeolite A x x

S-Methoprene x x x

Sodium 2-biphenylate x x

Sodium Cacodylate x x x

Sodium dichloroisocyanurate dihydrate x x x Annex II

Sodium hypochlorite x x x x x

Sodium p-chloro-m-cresolate x

Sodium pyrithione x

Spinosad x x x

Sulfuryl fluoride x x x

Sulphur dioxide x x x

Symclosene x x x

TCDO x x

Technical grade imazalil x x x

Tetramethrin x x x

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common name 3 4 5 18 19 20 PPP MRL

VMP MRL

Current or

Former PPP

Thiamethoxam x x x

Tosylchloramide sodium - Chloramin T x x x

Transfluthrin x

Triclosan x

Triflumuron x x x

Troclosene sodium x x x

ZE-TDA x

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Annex II

List of commodities for which MRLs are established under Regulation 396/2005

x 0x00000 x. FRUIT FRESH OR FROZEN; NUTS2 0xx0000 (i) Citrus fruit

4 0xx00x0 Grapefruit (Shaddocks, pomelos, sweeties, tangelo, ugli and other hybrids)

4 0xx0020 Oranges (Bergamot, bitter orange, chinotto and other hybrids)4 0xx0030 Lemons (Citron, lemon )4 0xx0040 Limes

4 0xx0050 Mandarins (Clementine, tangerine and other hybrids)4 0xx0990 Others2 0x20000 (ii) Tree nuts (shelled or unshelled)4 0x200x0 Almonds4 0x20020 Brazil nuts4 0x20030 Cashew nuts4 0x20040 Chestnuts4 0x20050 Coconuts4 0x20060 Hazelnuts (Filbert)4 0x20070 Macadamia4 0x20080 Pecans4 0x20090 Pine nuts4 0x20x00 Pistachios4 0x20xx0 Walnuts4 0x20990 Others2 0x30000 (iii) Pome fruit4 0x300x0 Apples (Crab apple)4 0x30020 Pears (Oriental pear)4 0x30030 Quinces4 0x30040 Medlar4 0x30050 Loquat4 0x30990 Others2 0x40000 (iv) Stone fruit4 0x400x0 Apricots4 0x40020 Cherries (sweet cherries, sour cherries)4 0x40030 Peaches (Nectarines and similar hybrids)4 0x40040 Plums (Damson, greengage, mirabelle)4 0x40990 Others2 0x50000 (v) Berries & small fruit3 0x5x000 (a) Table and wine grapes 4 0x5x0x0 Table grapes4 0x5x020 Wine grapes3 0x52000 (b) Strawberries 3 0x53000 (c) Cane fruit 4 0x530x0 Blackberries

4 0x53020 Dewberries (Loganberries, Boysenberries, and cloudberries)4 0x53030 Raspberries (Wineberries )4 0x53990 Others3 0x54000 (d) Other small fruit & berries 4 0x540x0 Blueberries (Bilberries cowberries (red bilberries))4 0x54020 Cranberries4 0x54030 Currants (red, black and white)

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4 0x54040 Gooseberries (Including hybrids with other ribes species)4 0x54050 Rose hips4 0x54060 Mulberries (arbutus berry)4 0x54070 Azarole (mediteranean medlar)

4 0x54080Elderberries (Black chokeberry (appleberry), mountain ash, azarole, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries)

4 0x54990 Others2 0x60000 (vi) Miscellaneous fruit3 0x6x000 (a) Edible peel4 0x6x0x0 Dates4 0x6x020 Figs4 0x6x030 Table olives 4 0x6x040 Kumquats (Marumi kumquats, nagami kumquats)4 0x6x050 Carambola (Bilimbi)4 0x6x060 Persimmon

4 0x6x070Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry (grumichama), Surinam cherry)

4 0x6x990 Others3 0x62000 (b) Inedible peel, small4 0x620x0 Kiwi4 0x62020 Lychee (Litchi) (Pulasan, rambutan (hairy litchi))4 0x62030 Passion fruit4 0x62040 Prickly pear (cactus fruit)4 0x62050 Star apple

4 0x62060American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote)

4 0x62990 Others3 0x63000 (c) Inedible peel, large4 0x630x0 Avocados4 0x63020 Bananas (Dwarf banana, plantain, apple banana)4 0x63030 Mangoes4 0x63040 Papaya4 0x63050 Pomegranate

4 0x63060Cherimoya (Custard apple, sugar apple (sweetsop) , llama and other medium sized Annonaceae)

4 0x63070 Guava4 0x63080 Pineapples4 0x63090 Bread fruit (Jackfruit)4 0x63x00 Durian4 0x63xx0 Soursop (guanabana)4 0x63990 Othersx 0200000 2. VEGETABLES FRESH OR FROZEN 2 02x0000 (i) Root and tuber vegetables3 02xx000 (a) Potatoes3 02x2000 (b) Tropical root and tuber vegetables

4 02x20x0 Cassava (Dasheen, eddoe (Japanese taro), tannia)4 02x2020 Sweet potatoes

4 02x2030 Yams (Potato bean (yam bean), Mexican yam bean)

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4 02x2040 Arrowroot4 02x2990 Others

3 02x3000 (c) Other root and tuber vegetables except sugar beet4 02x30x0 Beetroot4 02x3020 Carrots4 02x3030 Celeriac4 02x3040 Horseradish4 02x3050 Jerusalem artichokes4 02x3060 Parsnips4 02x3070 Parsley root

4 02x3080 Radishes (Black radish, Japanese radish, small radish and similar varieties)

4 02x3090 Salsify (Scorzonera, Spanish salsify (Spanish oysterplant))4 02x3x00 Swedes4 02x3xx0 Turnips4 02x3990 Others2 0220000 (ii) Bulb vegetables4 02200x0 Garlic4 0220020 Onions (Silverskin onions)4 0220030 Shallots4 0220040 Spring onions (Welsh onion and similar varieties)4 0220990 Others2 0230000 (iii) Fruiting vegetables3 023x000 (a) Solanacea4 023x0x0 Tomatoes (Cherry tomatoes, )4 023x020 Peppers (Chilli peppers)4 023x030 Aubergines (egg plants) (Pepino)4 023x040 Okra, ladys fingers4 023x990 Others3 0232000 (b) Cucurbits - edible peel4 02320x0 Cucumbers4 0232020 Gherkins4 0232030 Courgettes (Summer squash, marrow (patisson))4 0232990 Others3 0233000 (c) Cucurbits-inedible peel4 02330x0 Melons (Kiwano )4 0233020 Pumpkins (Winter squash)4 0233030 Watermelons4 0233990 Others3 0234000 (d) Sweet corn3 0239000 (e) Other fruiting vegetables 2 0240000 (iv) Brassica vegetables3 024x000 (a) Flowering brassica

4 024x0x0 Broccoli (Calabrese, Chinese broccoli, Broccoli raab)4 024x020 Cauliflower4 024x990 Others3 0242000 (b) Head brassica4 02420x0 Brussels sprouts

4 0242020Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)

4 0242990 Others3 0243000 (c) Leafy brassica

4 02430x0 Chinese cabbage (Indian (Chinese) mustard, pak choi, Chinese flat cabbage (tai 16

goo choi), peking cabbage (pe-tsai), cow cabbage)4 0243020 Kale (Borecole (curly kale), collards)4 0243990 Others3 0244000 (d) Kohlrabi2 0250000 (v) Leaf vegetables & fresh herbs

3 025x000 (a) Lettuce and other salad plants including Brassicacea4 025x0x0 Lamb´s lettuce (Italian cornsalad)

4 025x020Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)

4 025x030Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curld leave endive, sugar loaf)

4 025x040 Cress4 025x050 Land cress4 025x060 Rocket, Rucola (Wild rocket)4 025x070 Red mustard4 025x080 Leaves and sprouts of Brassica spp (Mizuna)4 025x990 Others3 0252000 (b) Spinach & similar (leaves)

4 02520x0 Spinach (New Zealand spinach, turnip greens (turnip tops))

4 0252020Purslane (Winter purslane (miners lettuce), garden purslane, common purslane, sorrel, glassworth)

4 0252030 Beet leaves (chard) (Leaves of beetroot)4 0252990 Others3 0253000 (c) Vine leaves (grape leaves)3 0254000 (d) Water cress3 0255000 (e) Witloof3 0256000 (f) Herbs4 02560x0 Chervil4 0256020 Chives

4 0256030Celery leaves (fennel leaves , Coriander leaves, dill leaves, Caraway leaves, lovage, angelica, sweet cisely and other Apiacea)

4 0256040 Parsley4 0256050 Sage (Winter savory, summer savory, )4 0256060 Rosemary4 0256070 Thyme ( marjoram, oregano)4 0256080 Basil (Balm leaves, mint, peppermint)4 0256090 Bay leaves (laurel)4 0256x00 Tarragon (Hyssop)4 0256990 Others2 0260000 (vi) Legume vegetables (fresh)

4 02600x0Beans (with pods) (Green bean (french beans, snap beans), scarlet runner bean, slicing bean, yardlong beans)

4 0260020 Beans (without pods) (Broad beans, Flageolets, jack bean, lima bean, cowpea)4 0260030 Peas (with pods) (Mangetout (sugar peas))

4 0260040 Peas (without pods) (Garden pea, green pea, chickpea)4 0260050 Lentils4 0260990 Others2 0270000 (vii) Stem vegetables (fresh)

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4 02700x0 Asparagus4 0270020 Cardoons4 0270030 Celery4 0270040 Fennel4 0270050 Globe artichokes4 0270060 Leek4 0270070 Rhubarb4 0270080 Bamboo shoots4 0270090 Palm hearts4 0270990 Others2 0280000 (viii) Fungi

4 02800x0 Cultivated (Common mushroom, Oyster mushroom, Shi-take)4 0280020 Wild (Chanterelle, Truffle, Morel ,)4 0280990 Others2 0290000 (ix) Sea weedsx 0300000 3. PULSES, DRY

4 03000x0Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)

4 0300020 Lentils4 0300030 Peas (Chickpeas, field peas, chickling vetch)4 0300040 Lupins4 0300990 Othersx 0400000 4. OILSEEDS AND OILFRUITS2 040x000 (i) Oilseeds4 040x0x0 Linseed4 040x020 Peanuts4 040x030 Poppy seed4 040x040 Sesame seed4 040x050 Sunflower seed4 040x060 Rape seed (Bird rapeseed, turnip rape)4 040x070 Soya bean4 040x080 Mustard seed4 040x090 Cotton seed4 040xx00 Pumpkin seeds4 040xxx0 Safflower4 040xx20 Borage4 040xx30 Gold of pleasure4 040xx40 Hempseed4 040xx50 Castor bean4 040x990 Others2 0402000 (ii) Oilfruits4 04020x0 Olives for oil production4 0402020 Palm nuts (palmoil kernels)4 0402030 Palmfruit4 0402040 Kapok4 0402990 Othersx 0500000 5. CEREALS4 05000x0 Barley 4 0500020 Buckwheat4 0500030 Maize4 0500040 Millet (Foxtail millet, teff)4 0500050 Oats4 0500060 Rice4 0500070 Rye4 0500080 Sorghum

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4 0500090 Wheat (Spelt Triticale)4 0500990 Others

x 0600000 6. TEA, COFFEE, HERBAL INFUSIONS AND COCOA

2 06x0000 (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis)2 0620000 (ii) Coffee beans2 0630000 (iii) Herbal infusions (dried)3 063x000 (a) Flowers4 063x0x0 Camomille flowers4 063x020 Hybiscus flowers4 063x030 Rose petals 4 063x040 Jasmine flowers 4 063x050 Lime (linden)4 063x990 Others3 0632000 (b) Leaves4 06320x0 Strawberry leaves4 0632020 Rooibos leaves4 0632030 Maté4 0632990 Others3 0633000 (c) Roots4 06330x0 Valerian root 4 0633020 Ginseng root4 0633990 Others3 0639000 (d) Other herbal infusions2 0640000 (iv) Cocoa (fermented beans)2 0650000 (v) Carob (st johns bread)

x 0700000 7. HOPS (dried) , including hop pellets and unconcentrated powderx 0800000 8. SPICES2 08x0000 (i) Seeds4 08x00x0 Anise4 08x0020 Black caraway4 08x0030 Celery seed (Lovage seed)4 08x0040 Coriander seed4 08x0050 Cumin seed4 08x0060 Dill seed4 08x0070 Fennel seed4 08x0080 Fenugreek4 08x0090 Nutmeg4 08x0990 Others2 0820000 (ii) Fruits and berries4 08200x0 Allspice 4 0820020 Anise pepper (Japan pepper)4 0820030 Caraway 4 0820040 Cardamom4 0820050 Juniper berries

4 0820060 Pepper, black and white (Long pepper, pink pepper)4 0820070 Vanilla pods4 0820080 Tamarind 4 0820990 Others2 0830000 (iii) Bark4 08300x0 Cinnamon (Cassia )4 0830990 Others2 0840000 (iv) Roots or rhizome

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4 08400x0 Liquorice4 0840020 Ginger 4 0840030 Turmeric (Curcuma)4 0840040 Horseradish4 0840990 Others2 0850000 (v) Buds4 08500x0 Cloves4 0850020 Capers4 0850990 Others2 0860000 (vi) Flower stigma4 08600x0 Saffron 4 0860990 Others2 0870000 (vii) Aril4 08700x0 Mace4 0870990 Othersx 0900000 9. SUGAR PLANTS4 09000x0 Sugar beet (root)4 0900020 Sugar cane4 0900030 Chicory roots 4 0900990 Others

x x000000 x0. PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS

2 x0x0000

(i) Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals other processed products such as sausages and food preparations based on these

3 x0xx000 (a) Swine 4 x0xx0x0 Meat4 x0xx020 Fat free of lean meat4 x0xx030 Liver4 x0xx040 Kidney4 x0xx050 Edible offal4 x0xx990 Others3 x0x2000 (b) Bovine4 x0x20x0 Meat4 x0x2020 Fat4 x0x2030 Liver4 x0x2040 Kidney4 x0x2050 Edible offal4 x0x2990 Others3 x0x3000 (c) Sheep4 x0x30x0 Meat4 x0x3020 Fat4 x0x3030 Liver4 x0x3040 Kidney4 x0x3050 Edible offal4 x0x3990 Others3 x0x4000 (d) Goat 4 x0x40x0 Meat4 x0x4020 Fat4 x0x4030 Liver4 x0x4040 Kidney4 x0x4050 Edible offal4 x0x4990 Others3 x0x5000 (e) Horses, asses, mules or hinnies

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4 x0x50x0 Meat4 x0x5020 Fat4 x0x5030 Liver4 x0x5040 Kidney4 x0x5050 Edible offal4 x0x5990 Others

3 x0x6000 (f) Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon4 x0x60x0 Meat4 x0x6020 Fat4 x0x6030 Liver4 x0x6040 Kidney4 x0x6050 Edible offal4 x0x6990 Others3 x0x7000 (g) Other farm animals (Rabbit, Kangaroo)4 x0x70x0 Meat4 x0x7020 Fat4 x0x7030 Liver4 x0x7040 Kidney4 x0x7050 Edible offal4 x0x7990 Others

2 x020000(ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd

4 x0200x0 Cattle4 x020020 Sheep4 x020030 Goat4 x020040 Horse 4 x020990 Others

2 x030000

(iii) Birds eggs, fresh preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter

4 x0300x0 Chicken 4 x030020 Duck4 x030030 Goose4 x030040 Quail 4 x030990 Others2 x040000 (iv) Honey (Royal jelly, pollen)

2 x050000 (v) Amphibians and reptiles (Frog legs, crocodiles)2 x060000 (vi) Snails2 x070000 (vii) Other terrestrial animal products

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