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 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: env-biocides@ec.europa.eu 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 products PT4: Food and feed area disinfectants PT5: Drinking water disinfectants PT18: Insecticides PT19: Repellents PT20: 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, 3 4 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 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. 2 processing and distribution. To this end, business operators are required to apply appropriate systems and procedures. 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- 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 3 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 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 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. 4 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 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 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 5 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. 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. 9 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996L0023:EN:NOT http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997D0747:EN:NOT 11 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998D0179:EN:NOT 6 10 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. 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. 12 http://ec.europa.eu/food/plant/protection/pesticides/multi-annual_control_programmes_en.htm http://www.crl-pesticides.eu/ 14 http://ec.europa.eu/food/fvo/index_en.htm 15 http://ec.europa.eu/food/food/rapidalert/index_en.htm 7 13 Annex I Substances included in the review programme for PT 3, 4, 5, 19 or 20 common name 3 2-Butanone, peroxide x 2-chloroacetamide x 2-Phenoxyethanol x 4 PPP 5 18 19 20 MRL VMP MRL Current or Former PPP Annex I x x Abamectin x x Acetamiprid x x x Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ x x ADBAC x x x x x x x ADBAS x Akacid x x x x Akacid forte x x x x alpha-Cypermethrin x Aluminium Phosphide x Ampholyt 20 x x Bacillus sphaericus strain 2362 x x Bardap 26 x Annex I x x x x Azamethiphos Bacillus subtilis x x Annex I, II, III x x x x x x x x Bendiocarb x Benzoic acid x x Biphenyl-2-ol x x BKC x x Bromoacetic acid x x Annex II (E210) x Annex II x 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 Calcium hypochlorite x Calcium magnesium oxide / dolomitic lime x x Annex II x 8 x x common name 3 Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime x Calcium oxide / lime / burnt lime / quicklime x 4 Carbon dioxide x CHDG VMP MRL Current or Former PPP x Annex II x x Annex II (E290) x PPP 5 18 19 20 MRL x x Chlorfenapyr x Chlorine x x x Chlorine dioxide x Chlorocresol x Chlorophene x x x Annex II Chrysanthemum cinerariaefolium, ext. x Annex II Cis-tricos-9-ene x Citriodiol x Clothianidin x Copper x Copper sulphate x Cyanamide x x x x x x x x Cyclopropanecarboxylic acid, 3-[(xZ)-2-chloro-3,3,3-trifluorox-propenyl]-2,2-dimethyl-, (2-methyl[x,x’-biphenyl]-3-ylmethyl ester, (xR,3R)-rel- / Bifenthrin / Biphenate 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 Decanoic acid x 2 x x x DEET x x Deltamethrin x Diamine x 9 x x x x x x Annex I x common name 3 4 PPP 5 18 19 20 MRL Dichlorvos x x Diflubenzuron x x Disodium peroxodisulphate / Sodium persulphate VMP MRL Current or Former PPP x Annex I x x d-Phenothrin x d-Tetramethrin x Empenthrin x Esbiothrin x Esfenvalerate x Ethanol x x x x x x Annex II x Etofenprox x x x Fipronil x x x Flufenoxuron x x x Formaldehyde x x Formic acid x x x x Geraniol x Glucoprotamin x Annex II x x Annex II x x x Glutaraldehyde x x Glycollic acid x x Glyoxal x x x Annex II x Hexaflumuron x Hydrogen cyanide x Hydrogen peroxide x x x x x x Icaridine x Annex II x x Imazalil x Imidacloprid x Imiprothrin x Iodine x x x x x Annex II IR3535 x L-(+)-lactic acid x Lambda cyhalothrin x x x x Lauric acid x Lavender, Lavandula hybrida, ext. / Lavandin oil x 10 Annex II x x x common name 3 4 PPP 5 18 19 20 MRL Magnesium Phosphide x Margosa extract x x x Current or Former PPP x x Methylneodecanamide / MNDA22 x Methynonylketone x Mixture of CMIT/MIT VMP MRL x x Naled x x x Nitrogen x x x Nonanoic acid x Octanoic acid x x PAP x x Pentapotassium bis(peroxymonosulphate) bis(sulphate) x x x Peracetic acid x x x Perestane x x Annex I x x x Annex I x x x Annex II x x Permethrin Peroxyoctanoic acid x x PHMB x x x Piperonyl butoxide / PBO Poly(hexamethylenebiguanide) x Polymer of formaldehyde and acrolein x x Prallethrin x Propan-1-ol x Propan-2-ol x PVP-iodine (see iodine) x Annex II Pyrethrins and Pyrethroids x Pyriproxyfen x Quaternary ammonium compounds, benzyl-Cx2-x4alkyldimethyl, chlorides (see ADBAC) x Quaternary ammonium compounds, benzyl-Cx2-x8alkyldimethyl, chlorides (see ADBAC) x Quaternary ammonium compounds, Cx2-x4alkyl[(ethylphenyl)methyl]dimethyl, chlorides (see ADBAC) x Quaternary ammonium compounds, di-C8-x0-alkyldimethyl, chlorides (see DDAC) x x x x x x x x x x x x 11 x x x x x x x common name Salicylic acid 3 4 x x PPP 5 18 19 20 MRL x x Silver Silver chloride x x x x x x Silver zeolite A x x x Annex II (E552) x S-Methoprene Sodium 2-biphenylate Annex II (E551) x Silver sodium hydrogen zirconium phosphate Current or Former PPP x Silicium dioxide / Kieselguhr Silicon dioxide – amorphous VMP MRL x x x x x x x Sodium Cacodylate Sodium dichloroisocyanurate dihydrate x x x Sodium hypochlorite x x x Sodium p-chloro-m-cresolate x Sodium pyrithione x Annex II x x Spinosad x x x Sulfuryl fluoride x x x Sulphur dioxide Symclosene x TCDO Technical grade imazalil x x x x x x x x x x Tetramethrin x x x Thiamethoxam x x x x x Tosylchloramide sodium - Chloramin T x x x Transfluthrin x Triclosan x Triflumuron x Troclosene sodium x ZE-TDA x x x 12 Annex II List of commodities for which MRLs are established under Regulation 396/2005 x 2 0x00000 0xx0000 x. FRUIT FRESH OR FROZEN; NUTS (i) Citrus fruit 4 0xx00x0 Grapefruit (Shaddocks, pomelos, sweeties, tangelo, ugli and other hybrids) 4 4 4 0xx0020 0xx0030 0xx0040 Oranges (Bergamot, bitter orange, chinotto and other hybrids) Lemons (Citron, lemon ) Limes 4 4 2 4 4 4 4 4 4 4 4 4 4 4 4 2 4 4 4 4 4 4 2 4 4 4 4 4 2 3 4 4 3 3 4 0xx0050 0xx0990 0x20000 0x200x0 0x20020 0x20030 0x20040 0x20050 0x20060 0x20070 0x20080 0x20090 0x20x00 0x20xx0 0x20990 0x30000 0x300x0 0x30020 0x30030 0x30040 0x30050 0x30990 0x40000 0x400x0 0x40020 0x40030 0x40040 0x40990 0x50000 0x5x000 0x5x0x0 0x5x020 0x52000 0x53000 0x530x0 Mandarins (Clementine, tangerine and other hybrids) Others (ii) Tree nuts (shelled or unshelled) Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts (Filbert) Macadamia Pecans Pine nuts Pistachios Walnuts Others (iii) Pome fruit Apples (Crab apple) Pears (Oriental pear) Quinces Medlar Loquat Others (iv) Stone fruit Apricots Cherries (sweet cherries, sour cherries) Peaches (Nectarines and similar hybrids) Plums (Damson, greengage, mirabelle) Others (v) Berries & small fruit (a) Table and wine grapes Table grapes Wine grapes (b) Strawberries (c) Cane fruit Blackberries 4 4 4 3 4 4 4 0x53020 0x53030 0x53990 0x54000 0x540x0 0x54020 0x54030 Dewberries (Loganberries, Boysenberries, and cloudberries) Raspberries (Wineberries ) Others (d) Other small fruit & berries Blueberries (Bilberries cowberries (red bilberries)) Cranberries Currants (red, black and white) 13 4 4 4 4 0x54040 0x54050 0x54060 0x54070 Gooseberries (Including hybrids with other ribes species) Rose hips Mulberries (arbutus berry) Azarole (mediteranean medlar) 4 4 2 3 4 4 4 4 4 4 0x54080 0x54990 0x60000 0x6x000 0x6x0x0 0x6x020 0x6x030 0x6x040 0x6x050 0x6x060 Elderberries (Black chokeberry (appleberry), mountain ash, azarole, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries) Others (vi) Miscellaneous fruit (a) Edible peel Dates Figs Table olives Kumquats (Marumi kumquats, nagami kumquats) Carambola (Bilimbi) Persimmon 4 4 3 4 4 4 4 4 0x6x070 0x6x990 0x62000 0x620x0 0x62020 0x62030 0x62040 0x62050 Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry (grumichama), Surinam cherry) Others (b) Inedible peel, small Kiwi Lychee (Litchi) (Pulasan, rambutan (hairy litchi)) Passion fruit Prickly pear (cactus fruit) Star apple 4 4 3 4 4 4 4 4 0x62060 0x62990 0x63000 0x630x0 0x63020 0x63030 0x63040 0x63050 American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote) Others (c) Inedible peel, large Avocados Bananas (Dwarf banana, plantain, apple banana) Mangoes Papaya Pomegranate 4 4 4 4 4 4 4 x 2 3 3 0x63060 0x63070 0x63080 0x63090 0x63x00 0x63xx0 0x63990 0200000 02x0000 02xx000 02x2000 Cherimoya (Custard apple, sugar apple (sweetsop) , llama and other medium sized Annonaceae) Guava Pineapples Bread fruit (Jackfruit) Durian Soursop (guanabana) Others 2. VEGETABLES FRESH OR FROZEN (i) Root and tuber vegetables (a) Potatoes (b) Tropical root and tuber vegetables 4 4 02x20x0 02x2020 Cassava (Dasheen, eddoe (Japanese taro), tannia) Sweet potatoes 4 02x2030 Yams (Potato bean (yam bean), Mexican yam bean) 14 4 4 02x2040 02x2990 Arrowroot Others 3 4 4 4 4 4 4 4 02x3000 02x30x0 02x3020 02x3030 02x3040 02x3050 02x3060 02x3070 (c) Other root and tuber vegetables except sugar beet Beetroot Carrots Celeriac Horseradish Jerusalem artichokes Parsnips Parsley root 4 02x3080 Radishes (Black radish, Japanese radish, small radish and similar varieties) 4 4 4 4 2 4 4 4 4 4 2 3 4 4 4 4 4 3 4 4 4 4 3 4 4 4 4 3 3 2 3 02x3090 02x3x00 02x3xx0 02x3990 0220000 02200x0 0220020 0220030 0220040 0220990 0230000 023x000 023x0x0 023x020 023x030 023x040 023x990 0232000 02320x0 0232020 0232030 0232990 0233000 02330x0 0233020 0233030 0233990 0234000 0239000 0240000 024x000 Salsify (Scorzonera, Spanish salsify (Spanish oysterplant)) Swedes Turnips Others (ii) Bulb vegetables Garlic Onions (Silverskin onions) Shallots Spring onions (Welsh onion and similar varieties) Others (iii) Fruiting vegetables (a) Solanacea Tomatoes (Cherry tomatoes, ) Peppers (Chilli peppers) Aubergines (egg plants) (Pepino) Okra, lady s fingers Others (b) Cucurbits - edible peel Cucumbers Gherkins Courgettes (Summer squash, marrow (patisson)) Others (c) Cucurbits-inedible peel Melons (Kiwano ) Pumpkins (Winter squash) Watermelons Others (d) Sweet corn (e) Other fruiting vegetables (iv) Brassica vegetables (a) Flowering brassica 4 4 4 3 4 024x0x0 024x020 024x990 0242000 02420x0 4 4 3 0242020 0242990 0243000 Broccoli (Calabrese, Chinese broccoli, Broccoli raab) Cauliflower Others (b) Head brassica Brussels sprouts Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage) Others (c) Leafy brassica 15 Chinese cabbage (Indian (Chinese) mustard, pak choi, Chinese flat cabbage (tai goo choi), peking cabbage (pe-tsai), cow cabbage) Kale (Borecole (curly kale), collards) Others (d) Kohlrabi (v) Leaf vegetables & fresh herbs 4 4 4 3 2 02430x0 0243020 0243990 0244000 0250000 3 4 025x000 025x0x0 4 025x020 (a) Lettuce and other salad plants including Brassicacea Lamb´s lettuce (Italian cornsalad) Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce) 4 4 4 4 4 4 4 3 025x030 025x040 025x050 025x060 025x070 025x080 025x990 0252000 Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curld leave endive, sugar loaf) Cress Land cress Rocket, Rucola (Wild rocket) Red mustard Leaves and sprouts of Brassica spp (Mizuna) Others (b) Spinach & similar (leaves) 4 02520x0 Spinach (New Zealand spinach, turnip greens (turnip tops)) 4 4 4 3 3 3 3 4 4 0252020 0252030 0252990 0253000 0254000 0255000 0256000 02560x0 0256020 Purslane (Winter purslane (miner s lettuce), garden purslane, common purslane, sorrel, glassworth) Beet leaves (chard) (Leaves of beetroot) Others (c) Vine leaves (grape leaves) (d) Water cress (e) Witloof (f) Herbs Chervil Chives 4 4 4 4 4 4 4 4 4 2 0256030 0256040 0256050 0256060 0256070 0256080 0256090 0256x00 0256990 0260000 Celery leaves (fennel leaves , Coriander leaves, dill leaves, Caraway leaves, lovage, angelica, sweet cisely and other Apiacea) Parsley Sage (Winter savory, summer savory, ) Rosemary Thyme ( marjoram, oregano) Basil (Balm leaves, mint, peppermint) Bay leaves (laurel) Tarragon (Hyssop) Others (vi) Legume vegetables (fresh) 4 02600x0 Beans (with pods) (Green bean (french beans, snap beans), scarlet runner bean, slicing bean, yardlong beans) 4 4 0260020 0260030 Beans (without pods) (Broad beans, Flageolets, jack bean, lima bean, cowpea) Peas (with pods) (Mangetout (sugar peas)) 4 4 0260040 0260050 Peas (without pods) (Garden pea, green pea, chickpea) Lentils 16 4 2 4 4 4 4 4 4 4 4 4 4 2 0260990 0270000 02700x0 0270020 0270030 0270040 0270050 0270060 0270070 0270080 0270090 0270990 0280000 Others (vii) Stem vegetables (fresh) Asparagus Cardoons Celery Fennel Globe artichokes Leek Rhubarb Bamboo shoots Palm hearts Others (viii) Fungi 4 4 4 2 x 02800x0 0280020 0280990 0290000 0300000 4 4 4 4 4 x 2 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 4 4 4 4 4 x 4 4 4 4 4 4 03000x0 0300020 0300030 0300040 0300990 0400000 040x000 040x0x0 040x020 040x030 040x040 040x050 040x060 040x070 040x080 040x090 040xx00 040xxx0 040xx20 040xx30 040xx40 040xx50 040x990 0402000 04020x0 0402020 0402030 0402040 0402990 0500000 05000x0 0500020 0500030 0500040 0500050 0500060 Cultivated (Common mushroom, Oyster mushroom, Shi-take) Wild (Chanterelle, Truffle, Morel ,) Others (ix) Sea weeds 3. PULSES, DRY Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas) Lentils Peas (Chickpeas, field peas, chickling vetch) Lupins Others 4. OILSEEDS AND OILFRUITS (i) Oilseeds Linseed Peanuts Poppy seed Sesame seed Sunflower seed Rape seed (Bird rapeseed, turnip rape) Soya bean Mustard seed Cotton seed Pumpkin seeds Safflower Borage Gold of pleasure Hempseed Castor bean Others (ii) Oilfruits Olives for oil production Palm nuts (palmoil kernels) Palmfruit Kapok Others 5. CEREALS Barley Buckwheat Maize Millet (Foxtail millet, teff) Oats Rice 17 4 4 4 4 0500070 0500080 0500090 0500990 Rye Sorghum Wheat (Spelt Triticale) Others x 0600000 6. TEA, COFFEE, HERBAL INFUSIONS AND COCOA 2 2 2 3 4 4 4 4 4 4 3 4 4 4 4 3 4 4 4 3 2 2 06x0000 0620000 0630000 063x000 063x0x0 063x020 063x030 063x040 063x050 063x990 0632000 06320x0 0632020 0632030 0632990 0633000 06330x0 0633020 0633990 0639000 0640000 0650000 (i) Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) (ii) Coffee beans (iii) Herbal infusions (dried) (a) Flowers Camomille flowers Hybiscus flowers Rose petals Jasmine flowers Lime (linden) Others (b) Leaves Strawberry leaves Rooibos leaves Maté Others (c) Roots Valerian root Ginseng root Others (d) Other herbal infusions (iv) Cocoa (fermented beans) (v) Carob (st johns bread) x x 2 4 4 4 4 4 4 4 4 4 4 2 4 4 4 4 4 0700000 0800000 08x0000 08x00x0 08x0020 08x0030 08x0040 08x0050 08x0060 08x0070 08x0080 08x0090 08x0990 0820000 08200x0 0820020 0820030 0820040 0820050 7. HOPS (dried) , including hop pellets and unconcentrated powder 8. SPICES (i) Seeds Anise Black caraway Celery seed (Lovage seed) Coriander seed Cumin seed Dill seed Fennel seed Fenugreek Nutmeg Others (ii) Fruits and berries Allspice Anise pepper (Japan pepper) Caraway Cardamom Juniper berries 4 4 4 4 2 4 0820060 0820070 0820080 0820990 0830000 08300x0 Pepper, black and white (Long pepper, pink pepper) Vanilla pods Tamarind Others (iii) Bark Cinnamon (Cassia ) 18 4 2 4 4 4 4 4 2 4 4 4 2 4 4 2 4 4 x 4 4 4 4 0830990 0840000 08400x0 0840020 0840030 0840040 0840990 0850000 08500x0 0850020 0850990 0860000 08600x0 0860990 0870000 08700x0 0870990 0900000 09000x0 0900020 0900030 0900990 Others (iv) Roots or rhizome Liquorice Ginger Turmeric (Curcuma) Horseradish Others (v) Buds Cloves Capers Others (vi) Flower stigma Saffron Others (vii) Aril Mace Others 9. SUGAR PLANTS Sugar beet (root) Sugar cane Chicory roots Others x x000000 x0. PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS x0x0000 x0xx000 x0xx0x0 x0xx020 x0xx030 x0xx040 x0xx050 x0xx990 x0x2000 x0x20x0 x0x2020 x0x2030 x0x2040 x0x2050 x0x2990 x0x3000 x0x30x0 x0x3020 x0x3030 x0x3040 x0x3050 x0x3990 x0x4000 x0x40x0 x0x4020 x0x4030 x0x4040 x0x4050 (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 (a) Swine Meat Fat free of lean meat Liver Kidney Edible offal Others (b) Bovine Meat Fat Liver Kidney Edible offal Others (c) Sheep Meat Fat Liver Kidney Edible offal Others (d) Goat Meat Fat Liver Kidney Edible offal 2 3 4 4 4 4 4 4 3 4 4 4 4 4 4 3 4 4 4 4 4 4 3 4 4 4 4 4 19 4 3 4 4 4 4 4 4 x0x4990 x0x5000 x0x50x0 x0x5020 x0x5030 x0x5040 x0x5050 x0x5990 Others (e) Horses, asses, mules or hinnies Meat Fat Liver Kidney Edible offal Others 3 4 4 4 4 4 4 3 4 4 4 4 4 4 x0x6000 x0x60x0 x0x6020 x0x6030 x0x6040 x0x6050 x0x6990 x0x7000 x0x70x0 x0x7020 x0x7030 x0x7040 x0x7050 x0x7990 (f) Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon Meat Fat Liver Kidney Edible offal Others (g) Other farm animals (Rabbit, Kangaroo) Meat Fat Liver Kidney Edible offal Others 2 4 4 4 4 4 x020000 x0200x0 x020020 x020030 x020040 x020990 (ii) Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd Cattle Sheep Goat Horse Others 2 4 4 4 4 4 2 x030000 x0300x0 x030020 x030030 x030040 x030990 x040000 (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 Chicken Duck Goose Quail Others (iv) Honey (Royal jelly, pollen) 2 2 2 x050000 x060000 x070000 (v) Amphibians and reptiles (Frog legs, crocodiles) (vi) Snails (vii) Other terrestrial animal products 20