Статья 17Директива № 2002/32/ЕС Европейского парламента и Совета Европейского Союза

От имени Европейского Парламента Председатель P.COX

Приложение I

МАКСИМАЛЬНЫЕ УРОВНИ НЕЖЕЛАТЕЛЬНЫХ ВЕЩЕСТВ, КАК УКАЗАНО В СТАТЬЕ 3(2)

<1> Максимальные уровни относятся к общему количеству мышьяка.

<2> По требованию компетентных органов ответственный оператор должен провести анализ, чтобы доказать, что содержание неорганического мышьяка ниже 2 частей на миллион. Указанный анализ имеет особое значение для вида морских водорослей Hizikia fusiforme.

<3> Фураж включает в себя сырье, предназначенное для корма животных, такое как сено, силос, свежая трава и др.

<4> Максимальные уровни относятся к общему количеству ртути.

<5> Максимальные уровни выражены в виде нитрита натрия.

<6> Максимальный уровень, установленный для премиксов, учитывает добавки с наибольшим содержанием свинца и кадмия, а не чувствительность различных видов животных к свинцу и кадмию. Как предусмотрено в Статье 16 Регламента (ЕС) 1831/2003 Европейского Парламента и Совета ЕС от 22 сентября 2003 г. о добавках в корма для животных (ОЖ № L 268, 18.10.2003, стр. 29), в целях защиты здоровья животных и населения производитель премиксов несет ответственность за обеспечение того, чтобы, помимо соблюдения максимальных уровней для премиксов, инструкции по применению премиксов соответствовали максимальным уровням для дополнительных и полноценных кормов.

<7> Максимальные уровни относятся к аналитическому определению фтора, при котором экстракцию проводят соляной кислотой 1 № в течение 20 минут при температуре окружающей среды. Могут быть применены эквивалентные процедуры экстракции, для которых можно продемонстрировать, что используемая процедура экстракции имеет равную эффективность.

<8> Процент содержания фосфора относится к корму с влажностью 12%.

<9> Максимальный уровень относится только к меламину. Включение структурно родственных соединений циануровой кислоты, аммелина и аммелида в максимальный уровень будет рассмотрено на более позднем этапе.

<10> Карбонат кальция и магния относится к природной смеси карбоната кальция и карбоната магния, описанной в Регламенте (ЕС) 575/2011 Европейской Комиссии от 16 июня 2011 г. о Каталоге кормовых материалов (ОЖ № L 159, 17.6.2011, стр. 25).

<11> Максимальный уровень применяется к консервированным кормам для домашних животных в том виде, в котором они продаются.

<12> Для определения содержания свинца в каолинитовой глине и в корме, содержащем каолинитовую глину, максимальный уровень относится к аналитическому определению свинца, при котором экстракцию проводят в азотной кислоте (5% w/w) в течение 30 минут при температуре кипения. Могут быть применены эквивалентные процедуры экстракции, для которых можно продемонстрировать, что используемая процедура экстракции имеет равную эффективность.

<13> Максимальный уровень применяется на сырую массу.

<2> Максимальный уровень для альдрина и дильдрина, отдельно или в сочетании, выражается как дильдрин.

<3> Система нумерации в соответствии с Parlar предваряется либо CHB или «Parlar»:

CHB 26: 2-эндо,3-экзо,5-эндо,6-экзо,8,8,10,10-октахлорборнан,

CHB 50: 2-эндо,3-экзо,5-эндо,6-экзо,8,8,9,10,10-нонахлорборнан,

CHB 62: 2,2,5,5,8,9,9,10,10-нонахлорборнан.

<4> Дихлордифенилтрихлорметилметан — прим. перевод.

<1> Концентрации с верхней границей; концентрации с верхней границей рассчитываются исходя из предположения, что все значения различных конгенеров ниже предела количественной оценки равны пределу количественной оценки.

<2> Таблица TEF (= коэффициенты токсической эквивалентности) для диоксинов, фуранов и диоксиноподобных PCBs:

ВОЗ-TEFs для оценки риска для человека на основе заключений, принятых по итогам заседания экспертов (ВОЗ) — Заседание экспертов Международной программы по химической безопасности (IPCS), которое состоялось в Женеве в июне 2005 г. (Martin van den Berg et al., Переоценка факторов токсической эквивалентности диоксинов и диоксиноподобных соединений для человека и млекопитающих, осуществленная в 2005 г. Всемирной организацией здравоохранения. Токсикологические Науки 93(2), 223 — 241 (2006))

<3> Свежая рыба и другие водные животные, непосредственно поставляемые и используемые без промежуточной обработки для производства корма для пушных зверей, не подпадают под действие максимальных уровней, в то время как максимальные уровни 3,5 нг продукта ВОЗ-PCDD/F-TEQ/кг и 6,5 нг продукта ВОЗ-PCDD/F-PCB-TEQ/кг применимы к свежей рыбе и 20,0 нг продукта ВОЗ-PCDD/F-PCB-TEQ/кг применимы к печени рыб, используемой для непосредственного кормления домашних животных, животных зоопарка и цирка или используемой в качестве кормового материала для производства корма для домашних животных. Продукты или обработанные животные белки, полученные от указанных животных (пушные звери, домашние животные, животные зоопарка и цирка), не могут входить в пищевую цепь и не могут быть скормлены сельскохозяйственным животным, которые содержатся, откармливаются или разводятся для производства пищевых продуктов.

<4> Свежая рыба и другие водные животные, непосредственно поставляемые и используемые без промежуточной обработки для производства корма для пушных зверей, не подпадают под действие максимальных уровней, в то время как максимальные уровни 75 мкг/кг продукта применимы к свежей рыбе и 200 мкг/кг продукта применимы к печени рыбы, используемой для непосредственного кормления домашних животных, животных зоопарка и цирка или используемой в качестве кормового материала для производства корма для домашних животных. Продукты или обработанные животные белки, полученные от указанных животных (пушные звери, домашние животные, животные зоопарка и цирка), не могут входить в пищевую цепь и не могут быть скормлены сельскохозяйственным животным, которые содержатся, откармливаются или разводятся для производства пищевых продуктов.

<5> Максимальный уровень применим также к кормовым добавкам, относящимся к функциональным группам веществ для контроля радионуклидной контаминации, и веществам для снижения контаминации кормов микотоксинами, которые также относятся к функциональным группам связующих и антислеживающих агентов.

<1> В настоящее время определяются с помощью аналитической микроскопии.

<2> Включает также фрагменты семенной шелухи.

<3> В случае представления однозначных доказательств того, что зерно и семена предназначены для измельчения или дробления, нет необходимости проводить очистку зерна и семян, содержащих соответствующие уровни семян Ambrosia spp., перед измельчением или дроблением при условии, что:

• груз транспортируется целиком на мукомольную или дробильную установку и мукомольную или дробильную установку заранее информируют о наличии высокого уровня семян Ambrosia spp. для того, чтобы принять дополнительные профилактические меры во избежание попадания в окружающую среду; и
• представляются убедительные доказательства того, что принимаются профилактические меры, чтобы избежать попадания семян Ambrosia spp. в окружающую среду при транспортировке на дробильную или мукомольную установку; и
• компетентный орган дает согласие на транспортировку, убедившись в выполнении вышеуказанных условий.

В случае невыполнения указанных условий груз должен быть очищен перед любой транспортировкой в ЕС, а отсевы должны быть надлежащим образом уничтожены.

<1> Таблица TEF (= коэффициенты токсической эквивалентности) для диоксинов, фуранов и диоксиноподобных PCBs:

ВОЗ-TEFs для оценки риска для человека на основе заключений, принятых по итогам заседания экспертов (ВОЗ) — Заседание экспертов Международной программы по химической безопасности (IPCS), которое состоялось в Женеве в июне 2005 г. (Martin van den Berg et al., Переоценка факторов токсической эквивалентности диоксинов и диоксиноподобных соединений для человека и млекопитающих, осуществленная в 2005 г. Всемирной организацией здравоохранения. Токсикологические Науки 93(2), 223 — 241 (2006))

<2> Концентрации с верхней границей; концентрации с верхней границей рассчитываются исходя из предположения, что все значения различных конгенеров ниже предела количественной оценки равны пределу количественной оценки.

<3> Идентификация источника контаминации. Как только источник будет идентифицирован, примите соответствующие меры, если это возможно, для уменьшения или ликвидации источника контаминации.

(b) Council Directive 96/25/EC and Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs <*>;

<*> (2) OJ L 86, 6.4.1979, p. 30. Directive as last amended by the European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).

(c) Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables <1>, Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals <2>, 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 <3> 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 <4>, where these residues are not listed in Annex I to this Directive;

<1> OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).

<2> OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/23/EC (OJ L 64, 7.3.2002, p. 13).

<2> OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2002/23/EC.

<4> OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2002/23/EC.

(d) Community legislation concerning veterinary matters relating to public health and animal health;

(e) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition <*>;

<*> OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(f) Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes <*>.

<*> OJ L 237, 22.9.1993, p. 23. Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).

(d) «premixtures» shall mean mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs;

(e) «compound feedingstuffs» shall mean mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;

(f) «complementary feedingstuffs» shall mean mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if used in combination with other feedingstuffs;

(g) «complete feedingstuffs» shall mean mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;

(h) «products intended for animal feed» shall mean feed materials, premixtures, additives, feedingstuffs and all other products intended for use or used in animal feed;

(i) «daily ration» shall mean the average total quantity of feedingstuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age class and yield, to satisfy all its needs;

(j) «animals» shall mean animals belonging to species normally fed and kept or consumed by man as well as animals living freely in the wild in cases where they are fed with feedingstuffs;

(k) «putting into circulation» or «circulation» shall mean the holding of products intended for animal feed for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale or other forms of transfer themselves;

(l) «undesirable substance» shall mean any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production.

1. Products intended for animal feed may enter for use in the Community from third countries, be put into circulation and/or used in the Community only if they are sound, genuine and of merchantable quality and therefore when correctly used do not represent any danger to human health, animal health or to the environment or could adversely affect livestock production.

2. In particular, products intended for animal feed shall be deemed not to be in conformity with paragraph 1 if the level of undesirable substances they contain does not comply with the maximum levels laid down in Annex I.

1. Member States shall prescribe that the undesirable substances listed in Annex I may be tolerated in products intended for animal feed only subject to the conditions laid down therein.

2. In order to reduce or eliminate sources of undesirable substances of products intended for animal feed, Member States, in cooperation with economic operators, shall carry out investigations to identify the sources of undesirable substances, in cases where the maximum levels are exceeded and in cases where increased levels of such substances are detected, taking into account background levels. For a uniform approach in cases of increased levels it may be necessary to set action thresholds to trigger such investigations. These may be laid down in Annex II.

Member States shall transmit to the Commission and the other Member States all relevant information and findings of the source and the measures taken to reduce the level or elimination of the undesirable substances. This information shall be transmitted in the frame of the annual report to be transmitted to the Commission according to the provisions of Article 22 of Directive 95/53/EC except in those cases where the information is of immediate relevance for the other Member States. In this latter case, the information shall be transmitted immediately.

1. Where a Member State has grounds, based on new information or a reassessment of existing information made since the provisions in question were adopted, demonstrating that a maximum level fixed in Annex I or an undesirable substance not listed therein present a danger to animal or human health or to the environment, that Member State may provisionally reduce the existing maximum level, fix a maximum level or prohibit the presence of that undesirable substance in products intended for animal feed. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.

2. An immediate decision shall be taken as to whether Annexes I and II should be amended. The Commission is empowered to adopt delegated acts in accordance with Article 10a amending those Annexes.

Where, in the case of those amendments, imperative grounds of urgency so require, the procedure provided for in Article 10b shall apply to delegated acts adopted pursuant to this Article.

The Member State may maintain the measures it has implemented as long as the Commission has not taken any decision.

• shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to paragraph 1, in accordance with the regulatory procedure referred to in Article 11(2),
• is empowered to adopt delegated acts in accordance with Article 10a in order to supplement this Directive by defining acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes.

3. Member States shall ensure that measures are taken to guarantee the correct application of any acceptable processes pursuant to paragraph 2 and the conformity of the detoxified products intended for animal feed with the provisions of Annex I.

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 7(2) and Article 8(1) and (2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of power referred to in Article 7(2) and Article 8(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 7(2) and Article 8(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months from the notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

1. Directive 1999/29/EC is hereby repealed as from 1 August 2003, without prejudice to the obligations of the Member States to comply with the deadlines set out in Part B of Annex III thereto for the transposition of the Directives listed in Part A of that Annex.

2. References to Directive 1999/29/EC shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex III.

The measures adopted shall apply as from 1 August 2003.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for making such reference shall be adopted by Member States.

Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

<2> Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of inorganic arsenic is lower than 2 ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme.

<3> Forage includes products intended for animal feed such as hay, silage, fresh grass, etc.

<4> The maximum levels refer to total mercury.

<5> The maximum levels are expressed as sodium nitrite.

<6> The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed.

<7> Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 № for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

<10> Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25).

<11> The maximum level is applicable to canned pet food as sold.

<12> For the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5% w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

<1> Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

<2> Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:

WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) — International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223 — 241 (2006))

Abbreviations used: «T» = tetra; «Pe» = penta; «Hx» = hexa; «Hp» = hepta; «O» = octa; «CDD» = chlorodibenzodioxin; «CDF» = chlorodibenzofuran; «CB» = chlorobiphenyl.

<3> Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

<4> Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 mg/kg product are applicable to fresh fish and 200 mg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

<*> The maximum level is also applicable to the feed additives belonging to the functional groups of substances for the control of radionuclide contamination and substances for reduction of the contamination of feed by mycotoxins which are also belonging to the functional groups of binders and anti-caking agents.

<2> Includes also seed husk fragments.

<3> In case unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing con-compliant levels of seeds of Ambrosia spp. before milling or crushing on the condition that:

• the consignment is transported as a whole to the milling or crushing plant, and — the milling or crushing plant is informed in advance of the presence of high level of Ambrosia spp. seeds in order take additional prevention measures to avoid dissemination into the environment, and
• solid evidence is provided that prevention measures are taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport to the crushing or milling plant, and
• the competent authority agrees to the transport, after having ensured that the abovementioned conditions are fulfilled.

In case these conditions are not fulfilled, the consignment must be cleaned before any transport into the EU and the screenings must be appropriately destroyed.

<1> Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 29).

<2> The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50% of the maximum levels established in the feed when the instructions for use of the premixture are followed.

SECTION: DIOXINS AND PCBs

<2> Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

<3> Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

(4) In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

Annex III

CORRELATION TABLE