MULTIANNUAL CONTROL PLAN FOR PESTICIDE RESIDUES

Transcription

1 MULTIANNUAL CONTROL PLAN FOR PESTICIDE RESIDUES CZECH REPUBLIC January 2012 In accordance with the Article 30 of the Regulation (EC) No 396/2005, the multiannual control plan for pesticide residues in the Czech Republic for period is being submitted. Prepared by: Ministry of Health Section of Chief Officer for Public Health Protection and Viceminister for Promotion and Protection of Public Health Department of Public Health Protection Discussed and approved by the Interministerial Working Group for Pesticide Residues Authorized by: Viera Šedivá, M.D. Deputy of the Chief Officer for Public Health Protection

2 Multiannual Control Plan for Pesticide Residues , Czech Republic Content 1. Introduction 2. Legal basis 2.1. EU Level 2.2. National Level 3. Definitions and Terminology 4. Competent Authorities of Public Administration 4.1. Central Administration Authorities 4.2. Official Control Authorities 5. Control Programme 5.1. Scope of the Programme 5.2. Criteria used for drawing up the Programme Selection of Commodities Number of Samples Pesticide Residues to be Analysed 6. Official Laboratories 7. Final provisions 8. Annex Pesticide Residues to be analyzed 2

3 Multiannual Control Plan for Pesticide Residues , Czech Republic 1. INTRODUCTION The Regulation of the European Parliament and Council (EC) No 396/2005 of 2005 on maximum pesticide residues limits in products of both plant and animal origin has become fully applicable as of 1 September The new harmonized rules for pesticide residues at the Community level have been introduced by this legislation, which represents a substantial simplification. The Regulation (EC) No 396/2005 is directly related to public health. The requirement of assurance of a high level of consumer protection will be fulfilled by setting of harmonized maximum limits for pesticide residues (hereinafter MRL ) in or on products of plant and animal origin, based on risk assessment analysis taking into account good agricultural practice. Moreover, the level of consumer protection will be the same in all Member States of the European Union. Furthermore, the Regulation is important from the point of view of the internal market as it allows for fair economic competition. The Regulation covers more than 1100 pesticides used in agricultural production in and/or outside the European Union. The maximum limits of pesticide residues for a whole range of agricultural products are set therein ranging from meat, milk, fruits to nuts, spices and feedingstuffs, and the limits relate to both unprocessed and processed foodstuffs. The motivation, and a very important principle is that food and feed safety of the most vulnerable population groups such as infants and young children have been considered when setting the limits. Another very important principle is that food and feed safety take precedence over plant protection. The Regulation is regularly updated based on the risk assessment of EFSA and new scientific knowledge. Performance of official controls in the pesticide residues area is a necessary precondition for implementation of the Regulation. In order to ensure a uniform system and with respect to national specificities the Regulation requires to prepare national multiannual control programmes for pesticide residues controls by Member States. The national programmes for pesticide residue controls are submitted to the European Commission (DG SANCO) and all Member States and they are publicly available. 3

4 Multiannual Control Plan for Pesticide Residues , Czech Republic 2. LEGAL BASIS The legal basis is formed namely by the following legislation: 2.1. EU level 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 The Regulation provides a general legal framework, requirements of food law and procedures in food safety. The Regulation has quite a wide scope and covers both all products under the definition of food and all products coming into the food chain for the purpose of food production, regardless of specific provisions applying to such substances. According to this Regulation products damaging health or products unfit for human consumption are prohibited from being placed on the market, and operators in agri-food sectors are primarily responsible for following the requirements of the food law. Moreover, the Regulation has introduced the duty to establish a system of traceability which enables food and feed business operators to trace a product through the whole food chain or to withdraw a product from the market in case of non-compliance with the food law. Limitation or elimination of health risk or prevention of health risk is based on risk analysis, which is a systematic procedure for establishing effective, adequate and focused measures or other measures to protect human health. The Regulation is a legal basis for establishing the European Food Safety Authority (EFSA) as a reinforcement of the present system of scientific and technical support. The role of EFSA is to provide a comprehensive independent scientific view of the safety and other aspects of the whole food and feed supply chains, having a direct or indirect impact on the safety of the food and feed supply chains, animal health and welfare as well as plant health, or which may pose risks for human health even if they comply with the food law, such as pesticides or feed additives. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules The Regulation lays down a clear Community framework for a methodical control system based on harmonized rules and integrated controls in the whole food and feed chains in line with the principle from field to table. The purpose of the Regulation is to ensure that official controls of foodstuffs and feedingstuffs are performed regularly at an appropriate frequency and are based on risk analysis. It stipulates, among others, the requirements on staff performing official controls, types of official controls, the requirements on official laboratories and on analytical methods and the duty to elaborate multiannual control plans covering the whole food and feed chains. Regulation (EC) No 396/2005 of the European parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/41/EEC The Regulation introducing new harmonized rules for pesticide residues has become fully applicable as of 1 September By this Regulation the pending legislation has been simplified since pesticide residues levels are harmonized at the Community level and this legislation is binding and directly applicable in all Member States without any transposition into national legislation. 4

5 Multiannual Control Plan for Pesticide Residues , Czech Republic All decisions must be backed by scientific findings and advice and evaluation of a consumption basket, which is carried out by the European Food Safety Authority. All values are fixed on the base of the principles of risk analysis and for their fixing the worst possible model of use is applied. Fixing of the levels and its methodology is based on the same principle and any limits based on different principles which were not reasonably justifiable have been replaced by the new levels. The Member States may retain their levels if such levels are not set on the Community level, but only for a transitional period until they are fully harmonized. The Regulation lays down new obligations for Member States, namely as regards performing of official controls and submission of reports on their results. The Member States are obliged to prepare multiannual control programmes for pesticide residues and they are also obliged to submit a yearly report on results of official controls on pesticide residues. One of the new obligations is also publishing the control programmes and their results, which also have to be forwarded to the Commission, EFSA and all Member States. Regulation of the Commission (EC) No 178/2006 of 1 February 2006 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council to establish Annex I listing the food and feed products to which maximum levels for pesticide residues apply By this Regulation the Annex I has been established, which is necessary for application of Annexes II, III and IV of this Regulation. This Regulation lists all products for which Community or national MRLs currently exist as well as those to which it is appropriate to apply harmonised MRLs. Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards implementation powers conferred on the Commission This regulation stipulates that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementation powers conferred on the Commission. This Decision, however, has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of the basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia by deleting some of those elements or by supplementing the instrument with new non-essential elements. For this reason Regulation (EC) No 396/2005 had to be amended in order to adjust procedures for adoption of amendments and measures including relevant deadlines. Moreover, the case of urgent procedures, in particular where a risk to human or animal health exists and therefore the usual deadlines for the regulatory procedure with scrutiny cannot be complied with, is described. Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto This Regulation represents the last one by which Annexes I, II, III and IV mentioned in Article 50 of the Regulation (EC) No 396/2005 are established, which means that Chapters II, III and V apply as of six months from the publication of this Regulation, and the same applies to MRLs setting there. Annex II incorporates the maximum residue levels for the products covered by Annex I of the Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin and Council Directive 90/642/EEC of 27 November 1990 on the fixing of 5

6 Multiannual Control Plan for Pesticide Residues , Czech Republic maximum levels for pesticide residues in and on certain products of plant origin, including fruit and taking into account the criteria mentioned in Article 14(2) of the Regulation (EC) No 396/2005. According to Article 22(1) of the Regulation (EC) No 396/2005, Annex III establishes temporary MRLs for active substances for which a decision on inclusion in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market has not yet been taken. When establishing those MRLs the remaining MRLs in Annex II to Council Directive 76/895/EEC and hitherto unharmonised national MRLs are to be taken into account. Those MRLs have to meet certain requirements. Article 16(1) of Regulation (EC) No 396/2005 also provides that Annex III may contain other categories of MRLs. These include MRLs for new agricultural products included in Annex I of the Regulation, for which no MRLs were set in Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. In order to distinguish between the MRLs referred to in recital 3 and the MRLs mentioned in recital 4, it is appropriate to divide Annex III into several parts. As regards the national MRLs notified by Member States, the Member States concerned have communicated the required information and the European Food Safety Authority has published reasoned opinions for each crop/pesticide combination. Based on those opinions temporary MRLs can be set provided they do not present an unacceptable risk to consumers. Substances for which it has been established in accordance with Article 5(1) of Regulation that no MRLs are required are included in Annex IV to that Regulation, however, the EFSA has also published a reasoned opinion for all active substances listed in Annex IV. Commission Regulation (EC) No 260/2008 of 18 March 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annex VII listing active substance/product combinations covered by a derogation as regards post harvest treatments with a fumigant This regulation supplements the Annex VII to the Regulation by means of which derogations from the maximum residue levels set out in Annexes II and III for certain crops and pesticides required by certain Member States are covered. Such a derogation allows Member States to authorise, in addition to a post-harvest treatment with a fumigant on their own territory, residue levels for active substances which exceed the limits specified in those Annexes in order to prevent trade disruption of stored products that underwent post-harvest treatments with fumigants. Commission Regulation (EC) No 839/2008 of 31 July 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards Annexes II, III and IV on maximum residue levels of pesticides in or on certain products For the products covered by Annex I, Annex II contains the maximum residue levels (MRLs) provided for under Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin and Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables. MRLs for permethrin (previous Commission Directives 2002/66/EC and 98/82/EC) and for propham are included (previous Commission Directive 2000/82/EC). Annex III establishes temporary MRLs for active substances for which a decision on inclusion in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market has not yet been taken. When establishing those MRLs the hitherto unharmonised national MRLs, which nevertheless have to meet certain requirements, were taken into consideration. In accordance with the Article 16 (1) the Annex III may contain other categories of MRLs. These include MRLs for new agricultural products included in Annex I of the Regulation, for which no MRLs were set in Directives 86/362/EEC, 6

7 Multiannual Control Plan for Pesticide Residues , Czech Republic 86/363/EEC and 90/642/EEC. Certain Member States have requested additional active substances to be included in Annex IV. Information provided by the Member States was evaluated and based on this information it was concluded that it is appropriate to include these substances in Annex IV. Commission Regulation (EC) No 256/2009 of 23 March 2009 amending Annexes II and III to the Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin and fludioxonil in or on certain products For azoxystrobin and fludioxonil maximum residue levels (MRLs) were set in Annexes II and III to the Regulation (EC) No 396/2005 respectively. As regards azoxystrobin, in the context of a new authorisation for use of that plant protection product on turnips, an application was made by an applicant in a third country in which the authorised use of that plant protection product leads to residues exceeding the MRL for pomegranates, as set out in Annex III to that Regulation. Both applications were evaluated by the EFSA, which concluded that the two modifications to the MRLs requested were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to both substances via consumption of all food products that may contain the two substances, nor the short-term exposure due to extreme consumption of turnips or pomegranates indicated a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) could be exceeded. Commission Regulation (EC) No 822/2009 of 27 August 2009 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, atrazine, chlormequat, cyprodinil, dithiocarbamates, fludioxonil, fluroxypyr, indoxacarb, mandipropamid, potassium tri-iodide, spirotetramat, tetraconazole, and thiram in or on certain products For azoxystrobin, atrazine, chlormequat, cyprodinil, dithiocarbamates, indoxacarb, fluroxypyr, tetraconazole and thiram maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005. For fludioxonil, mandipropamid and spirotetramat MRLs were set in Annex III to Regulation (EC) No 396/2005. For potassium tri-iodide no specific MRLs were set nor was the substance included in Annex IV to Regulation (EC) No 396/2005. In the context of the procedure for authorisation of a plant protection product containing the active substance cyprodinil for the use on herbs, beet leaves, beet roots and spinach, an application was submitted under Article 6(1) of Regulation (EC) No 396/2005 for modifications of the existing MRLs. As regards mancozeb (dithiocarbamates), such an application was made for the use on garlic. As regards indoxacarb, such an application was made for the use on raspberries, blackberries and Brussels sprouts. As regards fludioxonil, such an application was made for the use on carrots, beet roots, parsnips, horseradish, onions, salsify, parsley root, spinach and beet leaves. As regards fluroxypyr, such an application was made for the use on leeks. As regards mandipropamid, such as application was made for the use on red mustard, leaves and sprouts of brassica, spinach, purslane and beet leaves. As regards spirotetramat, such an application was made for the use on citrus fruit, pome fruit, apricots, peaches and grapes. As regards tetraconazole, such an application was made for the use on apricots. In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 applications for import tolerance were made for azoxystrobin on passion fruit, cyprodinil and fludioxonil on roots of herbal infusions and spices, fluroxypyr on tea and coffee beans, potassium tri-iodide on bananas, melons and grapes and thiram on bananas. 7

8 Multiannual Control Plan for Pesticide Residues , Czech Republic EFSA assessed the applications examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs. EFSA concluded in its reasoned opinions that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops indicated a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) could be exceeded. Commission Regulation (EC) No 1050/2009 of 28 October 2009 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products For azoxystrobin, acetamiprid, famoxadone, fenbutatin oxide, indoxacarb, ioxynil, mepanipyrim, thiacloprid and trifloxystrobin maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005. For clomazone, cyflufenamid, flufenoxuron, fluopicolide and prothioconazole, MRLs were set in Annex III to Regulation (EC) No 396/2005. For emamectin benzoate and pyridalyl no specific MRLs were set nor were the substances included in Annex IV to Regulation (EC) No 396/2005. In the context of a procedure, in accordance with Council Directive 91/414/EEC, for the authorisation of the use of a plant protection product containing the active substance azoxystrobin on beet leaves and broccoli an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modifications of the existing MRLs. The further applications were made as follows: - acetamiprid for the use on cress, spinach and herbs, except parsley, - clomazone for the use on herbs, - cyflufenamid for the use on oats. In view of that application, it is also necessary to modify the existing MRLs for animal products, since this cereal is used as feed. - emamectin benzoate for the use on pome fruit, peaches and nectarines, table and wine grapes, strawberries, tomatoes, aubergines, pepper, cucurbits (edible and inedible peel), cauliflower, broccoli, head cabbage, lettuce and other salad plants, scarole, herbs, fresh beans (with and without pods), peas with pods and artichokes, - famoxadone for the use on flowers of herbal infusions, - fenbutatin oxide for the use on tomatoes, - indoxacarb for the use on small fruits and berries except gooseberries and currants, - ioxynil for the use on rye and triticale. In view of that application, it is also necessary to modify the existing MRLs for meat, liver, kidney and fat from bovines, sheep and goats, since those cereals are used in feed for these animals. - mepanipyrim for the use on courgette, - prothioconazole for the use on head cabbage and Brussels sprouts, - pyridalyl for the use on tomatoes, aubergines, peppers, cucurbits (inedible peel), lettuce and cotton seed, - thiacloprid for the use on leeks and spring onions, - trifloxystrobin for the use on head cabbage, celery, blue berries, lettuce, herbs, scarole and Brussels sprouts. 8

9 Multiannual Control Plan for Pesticide Residues , Czech Republic In accordance with Article 6(2) of Regulation (EC) No 396/2005 applications were made for flufenoxuron on tea, fluopicolide on peppers and for trifloxystrobin on passion fruit. The authorised use of flufenoxuron on tea shrubs in Japan leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Japanese tea, a higher MRL is necessary. The authorised use of fluopicolide on pepper plants in the USA leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of American peppers, a higher MRL is necessary. The authorised use of trifloxystrobin on passion fruit in Kenya leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Kenyan passion fruits, a higher MRL is necessary. The European Food Safety Authority assessed the applications and the evaluation reports, examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs. The EFSA concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. Where the Authority recommended two MRL values for the same pesticideproduct combination as two different "risk management options", the lowest MRL was always opted for. Commission Regulation (EC) No 1097/2009 of 16 November 2009 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dimethoate, ethephon, fenamiphos, fenarimol, methamidophos, methomyl, omethoate, oxydemeton-methyl, procymidone, thiodicarb and vinclozolin in or on certain products For dimethoate, ethephon, fenamiphos, fenarimol, methamidophos, methomyl, omethoate, oxydemeton-methyl, procymidone, thiodicarb and vinclozolin maximum residue levels (MRLs) are set in Annex II to Regulation (EC) No 396/2005. In its opinion of 20 October 2008 concerning the Authority concluded for the current MRLs stipulated for: - dimethoate and omethoate for head cabbage, lettuce, cauliflower, cherries, wheat, peas with pods and Brussels sprouts, - ethephon for pineapples, currants, grapes and peppers, - fenamiphos for bananas, carrots, peppers, cucumbers, melons, head cabbage, and sugar beet, - fenarimol for bananas, tomatoes and peppers, - methamidophos for apricots, beans with pods and sugar beet, - methomyl and thiodicarb for grapes, head cabbage, lettuce, cauliflower, potatoes, tomatoes, aubergines, cucumbers, grapefruit, oranges, lemons, limes, mandarins, peaches, plums, peppers, apples, pears, quinces, bananas, mangoes, pineapples, carrots, celeriac, radishes, swedes, (water) melons, pumpkins, sweet corn, broccoli, kale, kohlrabi, scarole, leek and sugar beet, - oxydemeton-methyl for brussels sprouts, head cabbage, kohlrabi, lettuce and other salad plants including brassica, barley, oats and sugar beet, - procymidone for apricots, grapes, strawberries, raspberries, kiwi, (lamb s) lettuce, tomatoes, peppers, aubergines, cucumbers, gherkins, courgette, peaches, plums, pears, (water) melons, pumpkins, scarole, ruccola, witloof, beans with pods, sunflower seed, rapeseed, soya bean and products of animal origin, 9

10 Multiannual Control Plan for Pesticide Residues , Czech Republic - vinclozolin for apples, pears, table grapes, scarole, aubergine, Chinese cabbage, plums, apricots, lettuce, currants, witloof, strawberries, beans, hops, rape seed, carrots, shallots, spring onions, pumpkin, okra, cress, rocket and other salad plants and (water) melons, that there is a risk that the Acceptable Daily Intake and the Acute Reference Dose (ARfD) for one or more consumer groups will be exceeded. Therefore the current MRLs for these crops have been lowere. These new MRLs recommended by the Authority, are based on existing authorised agricultural uses that lead to lower residues or, when these do not exist, on the LOD. For ethephon on pineapples, this Regulation establishes an MRL that was not recommended by the Authority, but which was indicated as safe in the reasoned opinion of the Authority. Commission Regulation (EU) No 765/2010 of 25 August 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorothalonil clothianidin, difenoconazole, fenhexamid, flubendiamide, nicotine, spirotetramat, thiacloprid and thiamethoxam in or on certain products In the context of a procedure, in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, for the authorisation of the use of a plant protection product containing the active substance difenoconazole on swedes and turnips an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. As regards chlorothalonil, such an application was made for the use on barley. In view of that application, it is necessary to set MRLs for meat, fat, liver, kidney and milk from bovines, sheep and goats. As regards fenhexamid, such an application was made for the use on lettuce. As regards flubendiamide, such an application was made for the use on aubergine, cucurbits and beans with pods. As regards spirotetramat, such an application was made for the use on onions. As regards thiacloprid, such an application was made for the use on strawberries, and as regards thiamethoxam, such an application was made for carrots. In view of residues of clothianidin caused by the use of thiamethoxam, it is also necessary to modify the MRL for clothianidin on carrots. EFSA assessed the applications and the evaluation reports, examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs. The Authority concluded that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. As regards nicotine on wild fungi monitoring data showed that nicotine is present in wild mushrooms at levels that vary depending on the source and variety, but that exceed, in almost the totality of the samples, the default MRL of 0,01 mg/kg. These findings provide evidence of the unavoidable presence of nicotine in wild fungi, in particular ceps (Boletus edulis). Therefore, it is appropriate to set temporary MRLs for nicotine in wild fungi, based on the available monitoring data and on the opinion of the Authority. Those temporary MRLs should be reviewed within two years, to evaluate new data and information that will become available, including any scientific evidence on the natural occurrence or formation of nicotine in wild fungi. Commission Regulation (EU) No 893/2010 of 8 October 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 10

11 Multiannual Control Plan for Pesticide Residues , Czech Republic maximum residue levels for acequinocyl, bentazone, carbendazim, cyfluthrin, fenamidone, fenazaquin, flonicamid, flutriafol, imidacloprid, ioxynil, metconazole, prothioconazole, tebufenozide and thiophanate-methyl in or on certain products For bentazone, carbendazim, cyfluthrin, fenamidone, ioxynil, and thiophanate-methyl maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For acequinocyl, fenazaquin, flonicamid, Flutriafol, imidacloprid, metconazole, prothioconazole, and tebufenozide, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. In the context of a procedure, in accordance with Council Directive 91/414/EEC, for the authorisation of the use of a plant protection product containing the active substance bentazone on sweet corn an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. As regards acequinocyl, such an application was made for the use on oranges, mandarins, peaches, grapes, tomatoes and aubergines. As regards carbendazim, such an application was made for the use on lemon, limes and mandarins. As regards cyfluthrin, such an application was made for the use on courgettes, gherkins, beans with pods, peas with pods and potatoes. As regards fenamidone, such an application was made for the use on strawberries and cucurbits. As regards fenazaquin, such an application was made for the use on tea. As regards flonicamid, such an application was made for the use on citrus fruit, cherries, peppers, aubergines and peas without pods. As regards flutriafol, such an application was made for the use on apples, bananas and wine grapes. As regards imidacloprid, such an application was made for the use on rice. As regards ioxynil, such an application was made for the use on chives. As regards metconazole, such an application was made for the use on cherries, peaches, apricots, cotton seed, wheat and sugar beet. As regards prothioconazole, such an application was made for the use on broccoli and cauliflower. As regards tebufenozide, such an application was made for the use on rice. As regards thiophanate-methyl, such an application was made for the use on grapefruit, orange, lemon, limes and mandarins. EFSA concluded in its reasoned opinions that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. Commission Regulation (EU) No 310/2011 of 28 March 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aldicarb, bromopropylate, chlorfenvinphos, endosulfan, EPTC, ethion, fenthion, fomesafen, methabenzthiazuron, methidathion, simazine, tetradifon and triforine in or on certain products For aldicarb, bromopropylate, chlorfenvinphos, endosulfan, EPTC, ethion, fenthion, methidathion, simazine and triforine maximum residue levels (MRLs) are set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For fomesafen, methabenzthiazuron and tetradifon MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. Since those periods of grace have expired, it is appropriate to lower the MRLs of those substances to the relevant level of analytical determination (LOD). This should not apply to CXLs based on uses in third countries, provided that those CXLs are acceptable with regard to consumer safety. Nor should it apply in cases where MRLs have been specifically set as import tolerances. The EFSA was asked to give an opinion on CXLs based on uses in third 11

12 Multiannual Control Plan for Pesticide Residues , Czech Republic countries for bromopropylate, methidathion and triforine, examining in particular the risks to the consumer and, where relevant, to animals. In its opinion concerning bromopropylate the EFSA concluded that the existing CXLs for citrus fruit, pome fruit and grapes cannot be considered acceptable with regard to consumer exposure. Therefore the current MRLs for these crops should be lowered to the relevant LOD. In its opinion concerning methidathion the EFSA concluded that the available data do not support the existing MRLs on citrus fruit, cherries, peaches, plums, olives, onions, tomatoes, cucumber, head cabbage, dry peas, rape seed, sunflower seed, maize, tea, pome fruit and pineapples. As regards pome fruit and pineapples, however, the Authority proposed new MRLs, based on the available data. In respect of peas with pods and hops. In its opinion concerning triforine the EFSA concluded that the available data do not support the existing MRLs on pome fruit, stone fruit, currants, gooseberries, cucurbits (edible peel), barley, oats, rye, wheat and hops. Therefore the current MRLs for these crops should be lowered to the relevant LOD. The European Union reference laboratories for residues of pesticides were consulted on the need to adapt certain LODs. As regards bromopropylate, EPTC, fenthion, methabenzthiazuron, simazine, tetradifon and triforine, those laboratories concluded that for certain commodities technical development permits the setting of lower LODs. Furthermore, those laboratories advised to increase the LOD for aldicarb in tree nuts and bulb for chlorfenvinphos in tree nuts, bulb oilseeds and oil fruits, for endosulfan in bulb for ethion in tree nuts, bulb tea, coffee, herbal infusions and cocoa, hops and spices, for fenthion in tree nuts and bulb for fomesafen in tree nuts, bulb oilseeds and oil fruits, tea, coffee, herbal infusions and cocoa, hops and spices and for Methidathion in bulb oilseeds and oil fruits. In order to allow for the normal marketing, processing and consumption of products, the Regulation provides for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which the Authority s model for acute and chronic risk assessment shows that a high level of consumer protection is maintained. Commission Regulation (EU) No 460/2011 of 12 May 2011 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards the maximum residue level for chlorantraniliprole (DPX E-2Y45) in or on carrots For chlorantraniliprole (DPX E-2Y45) MRLs are set in Part A of Annex III to Regulation (EC) No 396/2005. In accordance with Article 8(4) of Council Directive 91/414/EEC on 23 August 2010 France notified to the Commission the temporary authorisation of a plant protection product containing chlorantraniliprole (DPX E-2Y45) to be used on carrots to control carrot flies, a danger that was unforeseeable and could not be contained by any other means. Consequently, France has notified to the other Member States, the Commission and the EFSA in accordance with Article 18(4) of Regulation (EC) No 396/2005 that it has authorised the placing on the market in its territory of carrots containing pesticide residues higher than the applicable MRL. France also submitted an appropriate risk assessment concluding that such carrots do not constitute an unacceptable risk, in particular that the proposed increased residue level does not lead to a risk for any consumer. The EFSA assessed the risk assessment submitted by France and gave a reasoned opinion on the proposed MRL. In this opinion the EFSA found the proposed MRL acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. Commission Regulation (EU) No 508/2011 of 24 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin, acetamiprid, cyprodinil, difenoconazole, 12

13 Multiannual Control Plan for Pesticide Residues , Czech Republic dimethomorph, fenhexamid, proquinazid, prothioconazole, pyraclostrobin, spirotetramat, thiacloprid, thiamethoxam and trifloxystrobin in or on certain products For abamectin, acetamiprid, fenhexamid, pyraclostrobin, thiacloprid and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyprodinil, difenoconazole, dimethomorph, proquinazid, prothioconazole, spirotetramat, and thiamethoxam, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. In the context of a procedure, in accordance with Council Directive 91/414/EEC for the authorisation of the use of a plant protection product containing the active substance fenhexamid on onions an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. As regards abamectin, such an application was made for the use on apricots and peaches. As regards acetamiprid, such an application was made for the use on land cress and red mustard. As regards cyprodinil, such application was made for the use in fresh lentils. As regards difenoconazole, such an application was made for the use on peppers and aubergines. As regards dimethomorph, such an application was made for the use in garlic, onions, shallots, aubergines and globe artichokes. As regards proquinazid, such an application was made for the use on strawberries. As regards prothioconazole, such an application was made for the use on various root vegetables As regards pyraclostrobin, such an application was made for the use on tomatoes, aubergines, globe artichokes and celeriac. As regards spirotetramat, such an application was made for the use in various crops outside the European Union. As regards thiacloprid, such an application was made for the use on cotton seed and figs. As regards thiamethoxam, such an application was made for the use in strawberries and beans (with pods). As regards trifloxystrobin, such an application was made for the use on leafy brassica. Regarding trifloxystrobin, the EFSA has reviewed not only the use on leafy brassica but also the animal feeding studies and has concluded that it is necessary to set MRLs for products of animal origin with an amended residue definition at the limit of determination for enforcement purposes. EFSA assessed the applications and the evaluation reports, and in its reasoned opinions concluded that all requirements with respect to data were met and that the modifications to the MRLs as recommended by the Authority were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. Commission Regulation (EU) No 520/2011 of 25 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, indoxacarb, metaflumizone, methoxyfenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and zoxamide in or on certain products For benalaxyl, carbofuran, carbosulfan, cypermethrin, indoxacarb, methoxyfenozide, paraquat, prochloraz, and zoxamide maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For boscalid, buprofezin, fluopicolide, hexythiazox, metaflumizone, prothioconazole and spirodiclofen, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for boscalid in a wide range of crops for modification of the existing MRLs. The authorised use of boscalid in NAFTA (North American Free Trade Agreement) countries lead 13

14 Multiannual Control Plan for Pesticide Residues , Czech Republic to higher residues than the MRLs in Annex III to Regulation (EC) No 396/2005. To avoid trade barriers for the importation of cherries, onions, spring onions, tomatoes, aubergines, cucumbers, melons, broccoli, head cabbage, basil, dry beans, dry peas, sunflower seed and rape seed, higher MRLs are necessary. The EFSA assessed the application and the evaluation report, examining in particular the risks to the consumer and where relevant to animals and gave a reasoned opinion on the proposed MRLs. It forwarded this opinion to the Commission and the Member States and made it available to the public. EFSA concluded in its reasoned opinion that all requirements with respect to data were met and that the modifications to the MRLs as recommended were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. On 9 July 2010 the Codex Alimentarius Commission (CAC) adopted Codex limits (CXLs) for benalaxyl, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, indoxacarb, metaflumizone, methoxyfenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and zoxamide. These CXLs should be included in Regulation (EC) No 396/2005 as MRLs, with the exception of those CXLs which are not safe for a European consumer group and for which the Union presented a reservation to the CAC based on a scientific report of the EFSA. Commission Regulation (EU) No 524/2011 of 26 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products For deltamethrin, ethofumesate, propiconazole, pymetrozine and pyrimethanil maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For tebuconazole, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For isopyrazam no MRLs were set before in any of the Annexes to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applied. Up to now, for biphenyl no specific MRLs were set nor was the substance included in Annex IV to Regulation (EC) No 396/2005. Biphenyl was formerly used as a plant protection product. In accordance with Article 18(1)(b) Regulation (EC) No 396/2005 the default MRL of 0.01 mg/kg is to apply to all products listed in Annex I thereto. In the context of a procedure, in accordance with Council Directive 91/414/EEC for the authorisation of the use of a plant protection product containing the active substance pymetrozine on spinach, purslane and beet leaves an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. As regards deltamethrin, such an application was made for the use on potatoes. As regards ethofumesate, such an application was made for the use in herbal infusions for leaves and flowers and thyme. As regards isopyrazam, such an application was made for the use on several cereals. As regards propiconazole, such an application was made for the use on table and wine grapes, and apples As regards pyrimethanil, such an application was made for the use on peas with pods. As regards tebuconazole, such an application was made for the use on various citrus fruit. As Regards biphenyl, the Commission received information from Germany and business operators showing the presence of biphenyl on fresh herbs and herbal infusions containing pesticide residues higher than the default MRL. Germany submitted an evaluation report and informed that due to the ubiquitous presence of this substance from various sources it is 14

15 Multiannual Control Plan for Pesticide Residues , Czech Republic impossible to produce herbs,tea rose hips, spices and herbal infusions containing residues of biphenyl complying with the MRL. Referring to the procedure described in Article 16(1) (a) of Regulation (EC) No 396/2005 Germany made an application for temporary MRLs to enable the placing on the market of the affected products. The EFSA assessed the applications and the evaluation reports, and in its reasoned opinions concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. For biphenyl the Authority recommended only to raise the MRLs for which data demonstrated that this was necessary. It also advised that because of analytical problems in some cases it might not be possible to enforce the existing MRL and suggested that the lowest limit of analytical determination (LOD) for these crops might be raised. Commission Regulation (EU) No 559/2011 of 7 June 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for captan, carbendazim, cyromazine, ethephon, fenamiphos, thiophanate-methyl, triasulfuron and triticonazole in or on certain products For captan, carbendazim, cyromazine, ethephon, fenamiphos, thiophanate-methyl, triasulfuron and triticonazole maximum residue levels (MRLs) are set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For captan the Commission was informed that uses on celery, spinach, and parsley were revoked and thus the corresponding MRLs could be reduced without requiring the opinion of the EFSA. For cyromazine an evaluation by the EFSA indicated that the MRL for lettuce may raise concerns of consumer protection. The EFSA recommended lowering that MRL. These concerns also apply to scarole. On the basis of additional data submitted by South Africa and Germany, the Authority further refined its earlier evaluation of the consumer exposure for carbendazim and thiophanatemethyl. It concluded that it is necessary to lower the MRLs as regards carbendazim for grapefruits, oranges, and tomatoes and as regards thiophanate-methyl for tomatoes. For ethephon, fenamiphos, triasulfuron and triticonazole, the Authority submitted reasoned opinions on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005. The EFSA concluded that it is necessary to lower the MRLs as regards triasulfuron for barley, oats, rye, and wheat and as regards fenamiphos for tomatoes, aubergines, peppers, water melons, courgettes, Brussels sprouts, bananas, peanuts and oilseeds and to raise the MRL for grapes. As regards triticonazole, the Authority concluded that no MRL needs to be modified. It is appropriate to move the MRLs on new commodities for these four substances, temporarily set in Part B of Annex III to Regulation (EC) No 396/2005, to Annex II to that Regulation. Commission Regulation (EU) No 812/2011 of 10 August 2011 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dimethomorph, fluopicolide, mandipropamid, metrafenone, nicotine and spirotetramat in or on certain products For dimethomorph, fluopicolide, mandipropamid, metrafenone, nicotine and spirotetramat maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. In the context of a procedure, in accordance with Council Directive 91/414/EEC, for the authorisation of the use of a plant protection product containing the active substance 15