Статья 23. Данная Директива должна вступить в силу на 20-ый день после опубликования в Официальном издании Европейского союза.Директива № 2009/41/ЕС Европейского парламента и Совета Европейского Союза

Данная Директива адресована Государствам-членам ЕС.

Совершено в Страсбурге, 6 мая 2009 года.

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Технология генетической модификации, указанная в пункте (b) (i) Статьи 2, среди прочего:

1. Технологические приемы рекомбинирования нуклеиновой кислоты, вовлекающие формирование новых комбинаций генетического материала вставкой молекул нуклеиновой кислоты, произведенных любым средством вне организма, в любой вирус, бактериальную плазмиду или другую векторную систему и их объединение в организм хозяина, в котором они не образуются естественным образом, но в котором они способны к длительному распространению.

2. Методы, вовлекающие прямое введение в микроорганизм наследственного материала, подготовленного вне микроорганизма, включая микроинъекцию, макроинъекцию и микрогерметизацию.

3. Слияние клеток или технологические приемы гибридизации, когда живые клетки с новыми комбинациями наследственного генетического материала сформированы через слияние двух или больше клеток посредством методов, которые не встречаются в естественных условиях.

Часть B

Технологические приемы, упомянутые в пункте (b) (ii) из Статьи 2, которые, как предполагается, не приводят к генетической модификации, при условии, что они не вовлекают использование молекул рекомбинантной нуклеиновой кислоты или ГММ, созданных технологиями/методами, отличными от технологий/методов, исключенных Частью A Приложения II:

1. оплодотворение в пробирке;

2. естественные процессы, такие как: спряжение, трансдукция, преобразование;

3. индукция полиплоидии.

Технологии или методы генетической модификации, производящие микроорганизмы, подлежащие исключению из сферы влияния данной Директивы при условии, что они не вовлекают использование молекул рекомбинантной нуклеиновой кислоты или ГММ, кроме произведенных одним или более упомянутых ниже технологий/методов:

1. Мутагенез.

2. Слияние клеток (включая слияние протопласта) прокариотических разновидностей, которые обменивают генетический материал известными физиологическими процессами.

3. Слияние клеток (включая слияние протопласта) любых разновидностей экариотов, включая производство гибридов и слияний клеток растения.

4. Самоклонирование, состоящее в удалении последовательностей нуклеиновой кислоты из клетки организма, которое (не) сопровождается перестановкой данной нуклеиновой кислоты (или синтетического эквивалента) полностью или в части, с возможным произведением ферментативной или механической обработки, в клетки тех же или тесно связанных разновидностей, которые могут обменять генетический материал естественными физиологическими процессами, когда произведенный в результате микроорганизм не может повлечь заражения людей, животных или растений.

Самоклонирование может включать использование рекомбинантных векторов с расширенной историей безопасного использования в специфических микроорганизмах.

Часть B

Данное Приложение описывает в общих чертах критерии, применимые при определении безопасности типов ГММ для здоровья человека и окружающей среды. Их пригодность для внедрения устанавливается на основании Части C. Указания по техническому руководству могут быть разработаны в соответствии с регулирующей процедурой, указанной в пункте 3 Статьи 20, чтобы облегчить исполнение и толкование данного Приложения.

1. Введение

Типы ГММ, частично указанные в Части C в соответствии с регулирующей процедурой и исследованием, указанным в пункте 2 Статьи 20, исключены из сферы применения данной Директивы. ГММ будет добавлен к списку в зависимости от конкретного случая, а исключение будет производиться в индивидуальном порядке. Данное исключение будет производиться только в том случае, когда условия использования ГММ удовлетворят требованиям пункта (c) Статьи 2. Данное правило не применяется к преднамеренному выпуску ГММ. В целях внесения ГММ в Часть C, необходимо, чтобы он удовлетворял следующим критериям:

Должно быть представлено зарегистрированное свидетельство безопасности организма.

В случае, когда любая нестабильность системы может отразиться на безопасности, необходимо представить доказательство стабильности.

3. Определенные критерии

3.1.1 Нетоксичным.

3.1.2 Неаллергенный.

ГММ не должен увеличивать аллергенность в результате генетической модификации, также он не должен быть установленным аллергеном, обладая, например, аллергенностью, сопоставимой с качествами микроорганизмов, указанных в Директиве 2000/54/ЕС.

ГММ не должен содержать известные вредоносные адвентивные вещества, такие как другие микроорганизмы, активные или латентные, существующие рядом или в ГММ, которые могли бы нанести ущерб здоровью человека и окружающей среде.

Измененный генетический материал не должен увеличивать вредоносное воздействие в результате преобразования; и при этом он не должен иметь более высокую способность к делению и передаче информации, чем исходный микроорганизм.

3.4. Безопасность для окружающей среды в случае существенного и непреднамеренного выпуска.

ГММ не должен оказывать непосредственное либо отсроченное отрицательное воздействие на окружающую среду в случае непреднамеренного и существенного выпуска.

ГММ, которые не соответствуют вышеупомянутым критериям, не могут быть включены в Часть C.

Часть C

Типы ГММ, которые соответствуют критериям, перечисленным в Части B:

... (будет выполнена в соответствии с регулирующей процедурой и исследованием, указанным в пункте 2 Статьи 20).

Приложение III

Настоящее Приложение описывает в общих чертах элементы, которые необходимо принимать во внимание, и процедуру, которая будет произведена в целях установления оценки негативного воздействия, указанной в пункте 2 Статьи 4. Примечания по техническому руководству <*> могут быть разработаны в соответствии с регулирующей процедурой, указанной в пункте 3 Статьи 20, в целях облегчения исполнения и толкования данного Приложения, что в особенности касается Секции B.

<*> См. Решение Европейской Комиссии 2000/608 ЕС от 27 сентября 2000 г. относительно замечаний к руководству по оценке степени риска, описанной в Приложении III Директивы Европейского Экономического Сообщества 90/219/ЕЭС о внедрении компонентов ГММ (ОЖ № L 258, 12.10.2000, стр. 43.)

• заражение животных и растений,
• отрицательное воздействие из-за невозможности противоэпидемического лечения или обеспечения эффективной профилактики,
• отрицательное воздействие из-за проникновения и распространения в окружающей среде,
• отрицательное воздействие из-за естественной передачи внедренного генетического материала в другие организмы.

2. Основания оценки, указанной в пункте 2 Статьи 4:

(a) определение любого потенциально опасного воздействия, в частности, связанного с:

(iii) вектором;

(iv) микроорганизмом донора (до тех пор, пока микроорганизм донора используется во время операционного цикла);

(v) результативным ГММ;

B. Процедура

3. Первая стадия процесса оценки заключается в определении вредоносности реципиента и, по возможности, микроорганизма донора, вектора или внедренного материала, включая любые изменения в текущих качествах реципиента.

4. В основном, только ГММ, показывающие следующие характеристики, могут соответствовать 1 классу опасности, согласно пункту 3 Статьи 4:

(ii) характер вектора и внедренного компонента не обеспечивает ГММ достаточным фенотипом для заражения человека, животного или растения <*> и окружающей среды;

<*> Это касается только животных и растений в окружающей среде, которые подверглись воздействию.

(iii) крайне низка вероятность того, что ГММ послужит причиной заражения человека, животного или растения <*> и окружающей среды.

<*> Это касается только животных и растений в окружающей среде, которые подверглись воздействию.

(i) особенности окружающей среды, которая, вероятно, будет затронута (например, есть ли в окружающей среде, которая вероятно будет затронута ГММ, известная биоматерия, на которую данный ГММ может неблагоприятно воздействовать);

(ii) особенности деятельности (например, ее масштаб и/или характер);

(iii) любые нестандартные операции (например, прививка животных ГММ; использование оборудования для производства аэрозолей).

Рассмотрение пунктов (i) - (iii) для специфической деятельности может увеличить, уменьшить или оставить неизменным уровень риска, связанный с ГММ, определенным пунктом 6.

8. Анализ, выполненный способом, описанным выше, приведет к присвоению деятельности одного из классов, указанных в пункте 3 Статьи 4.

9. Заключительная классификация деятельности по внедрению компонентов должна быть подтверждена после проведения оценки потенциального вредного воздействия.

Общие принципы

1. Данные таблицы представляют минимальные требования и меры, необходимые для каждого уровня сдерживания.

Сдерживание также достигается с помощью усовершенствования методов работы, обучения, применения оборудования сдерживания и специального оборудования особой конструкции. Для всех действий, вовлекающих ГММ, необходимо применять принципы положительной микробиологической практики и нижеследующие принципы техники безопасности и гигиены:

(i) снижать уровень воздействия ГММ как внутри замкнутого цикла, так и на окружающую среду;

(ii) осуществлять технические меры контроля и безопасности в лаборатории и усиливать их применением соответствующей защитной одежды и, при необходимости, оборудования;

(iii) тщательно проверять и совершенствовать меры по контролю и оборудование;

(iv) при необходимости проверять присутствие жизнеспособных организмов вне зоны первичной противоаварийной локализации;

(v) обеспечить соответствующее обучение персонала;

(vi) создать биологические комиссии по технике безопасности и, при необходимости, подкомиссии;

(xiii) письменно четко регламентировать стандартные рабочие процессы, в целях гарантии безопасности;

(xiv) иметь в наличии эффективные дезинфицирующие средства и определенные процедуры дезинфекции на случай утечки ГММ;

(xv) обеспечить безопасное хранение загрязненного лабораторного оборудования и материалов.

2. Показательные названия таблиц:

Таблица I A устанавливает минимальные требования к лабораторной деятельности.

Таблица I B содержит дополнения и изменения Таблицы I A для деятельности в парниках, вовлекающей ГММ.

Таблица I C содержит дополнения и изменения Таблицы I A для действий с животными, вовлекающими ГММ.

Таблица II представляет минимальные требования для деятельности, отличной от лабораторной.

3. В процессе исполнения требований данного Приложения Государства-члены ЕС могут включить в следующие таблицы общие принципы, изложенные в пунктах 1 и 2.

Таблица I A

<1> Изоляция — лаборатория должна быть обособлена в данном здании или находиться в отдельном здании.

<2> Тамбур — вход в лабораторию должен осуществляться через тамбур, который является отдельным помещением, изолированным от лаборатории. Вход и выход из тамбура необходимо обозначить табличками, к тому же рекомендуется блокировать двери.

<3> Действия, когда трансмиссия не производится через тамбур.

<4> Система HEPA — высокоэффективный микрочастотный воздух

<5> При совершении лабораторных действий в отсутствие тамбура

<6> В случаях, когда не все микрочастицы отсеиваются фильтрами HEPA, будут устанавливаться дополнительные требования к воздухоизвлечению.

<7> В соответствии с утвержденными процедурами, позволяет осуществлять безопасную передачу материала в паровой стерилизатор вне лаборатории и обеспечивает эквивалентный уровень защиты.

Термины «теплица» и «инкубатор» обозначают сооружение со стенами, крышей и полом, предназначенное для использования преимущественно в целях выращивания растений в управляемой и защищенной окружающей среде.

Все условия Таблицы I A должны применяться, учитывая следующие дополнения:

<*> Теплица должна состоять из капитального строения, с водонепроницаемой крышей, она должна быть расположена так, чтобы в нее не проникали стоки поверхностных вод. Должна иметь блокируемые двери, закрывающиеся автоматически

<**> В случаях, когда попадание может произойти через основание

Таблица I C

Сдерживание и другие защитные меры для действий с животными

Все условия Таблицы I A должны применяться со следующими дополнениями:

<*> Отделение с животными — здание или обособленное помещение в здании, в котором содержится оборудование, а также вспомогательные помещения, например, раздевалки, душевые, паровой стерилизатор, места хранения пищи и т.д.

<**> Оборудование с животными — запасники, отделения для размножения или размещения экспериментальных животных либо для проведения простейших хирургических процедур.

<***> Изоляторы — прозрачные боксы, где мелкие животные содержатся внутри либо вне клеток, для крупных животных комнаты изоляции могут быть более обустроенными.

Таблица II

Сдерживание и защитные меры для иных действий

Приложение V

Часть A

Информация, необходимая для уведомления, указанного в Статье 6:

• имя пользователя(ей), включая ответственных за наблюдение и безопасность,
• информация относительно обучения и квалификаций людей, ответственных за наблюдение и безопасность,
• описание биологических комитетов или подкомиссий,

• исключительно для риска опасности использования внедренных компонентов класса 1, требуется краткое изложение оценки, указанной в пункте 2 Статьи 4 и информация относительно управления отходами.

Часть B

Информация, необходимая для уведомления, указанного в Статье 8:

• дата подачи уведомления, указанного в Статье 6,
• личные данные персонала, ответственного за наблюдение и технику безопасности, а также информация относительно их обучения и квалификации,
• реципиент, донор и/или родительский используемый микроорганизм(ы) и, где используется система вектора хозяина,
• источник(и) и намеченная функция(и) генетического материала(ов), вовлеченного в модификацию(и),
• идентичность и характеристики ГММ,
• цель внедрения компонентов, включая ожидаемые результаты,
• приблизительные объемы культуры, которые будут использоваться,
• описание сдерживания и других защитных мер, которые будут применены, включая информацию об управлении отходами, включая отходы, которые будут произведены, их обработка, конечная форма и место назначения,
• резюме оценки, указанной в пункте 2 Статьи 4,
• при необходимости, в соответствии с пунктом 1 Статьи 13, представляется информация, необходимая компетентному органу, чтобы оценить план действия в условиях аварийной ситуации.

Часть C

(b) — реципиент или родительский микроорганизм(ы), который будет использоваться,

• система(ы) вектора хозяина, которая будет использоваться,
• источник(и) и предназначенная функция(и) генетического материала(ов), вовлеченного в модификацию(и),
• идентичность и характеристики ГММ,
• объем культуры, который будет использоваться;

(c) — описание сдерживания и других защитных мер, которые будут применены, включая информацию об управлении отходами, в том числе тип и форму отходов, которые будут произведены, их обработку, конечную форму и место захоронения,

• цель внедрения компонентов, включая ожидаемые результаты,
• описание частей установки;

(d) информация о планах техники безопасности и аварийного реагирования:

• любые риски, связанные с расположением установки,
• предпринятые меры по предупреждению чрезвычайных ситуаций, такие как установка спецоборудования, систем сигнализации и применение методов сдерживания,
• процедуры и планы относительно проверки эффективности мер по сдерживанию,
• описание информации, предоставленной работникам,
• информация, необходимая компетентному органу для оценки планов аварийного реагирования, в соответствии с пунктом 1 Статьи 13;

(e) копия оценки, указанной в пункте 2 Статьи 4.

Приложение VI

Часть A

Список последовательных поправок к аннулированной Директиве (согласно Статье 21)

Часть B

Сроки для преобразования в национальное право (согласно Статье 21)

Приложение VII

КОРРЕЛЯЦИОННАЯ ТАБЛИЦА

DIRECTIVE No. 2009/41/EC

(Strasbourg, 6.V.2009)

(Text with EEA relevance)

The European Parliament and the Council of the European Union,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee <*>,

<*> OJ C 162, 25.6.2008, p. 85.

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty <*>,

<*> Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 30 March 2009.

<*> OJ L 117, 8.5.1990, p. 1.

<**> See Annex VI, Part A.

(2) Under the Treaty, action by the Community relating to the environment must be based on the principle that preventive action is to be taken and must have as its objective, among other things, the preservation, protection and improvement of the environment and the protection of human health.

(3) Measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate.

(4) The development of biotechnology is such as to contribute to the economic expansion of the Member States. This involves the use of genetically modified micro-organisms (GMMs) in operations of various types and scales.

(5) The contained use of GMMs should be such as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of waste.

(7) Micro-organisms, if released into the environment in one Member State in the course of their contained use, may reproduce and spread, crossing national frontiers and thereby affecting other Member States.

(8) In order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish common measures for the evaluation and reduction of the potential risks arising in the course of all operations involving the contained use of GMMs and to set appropriate conditions of use.

(9) The precise nature and scale of risks associated with the contained use of GMMs are not yet fully known and the risk involved must be assessed on a case-by-case basis. In order to evaluate the risk to human health and the environment, it is necessary to lay down requirements for risk assessment.

(10) Contained uses of GMMs should be classified in relation to the risks they present to human health and the environment. Such classification should be in line with international practice and based on an assessment of the risk.

(11) In order to ensure a high level of protection, the containment and other protective measures applied to a contained use must correspond to the classification of the contained use. Where there is any uncertainty, the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data.

(12) For all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation.

(13) Appropriate containment measures should be applied at the various stages of an operation to control emissions and the disposal of material from contained uses of GMMs, and to prevent accidents.

(14) Any person, before undertaking for the first time the contained use of a GMM in a particular installation, should forward a notification to the competent authority so that the authority may satisfy itself that the proposed installation is appropriate for the purposes of carrying out the activity in a manner that does not present a hazard to human health and the environment.

(15) It is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of GMMs, taking account of the degree of risk involved.

(16) In the case of operations involving high risk, the consent of the competent authority should be given.

(17) The containment and other protective measures applied to contained uses should be reviewed periodically.

(18) It may be considered appropriate to consult the public on the contained use of GMMs.

(20) Appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety.

(21) Emergency plans should be established to deal effectively with accidents.

(22) If an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action.

(23) It is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents.

(24) The contained use of GMMs throughout the Community should be monitored, and to this end Member States should supply certain information to the Commission.

(25) In order to be considered safe for human health and the environment, GMMs should meet the list of criteria as defined in Annex II, Part B. To take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of that list, it is appropriate for the Council to revise those criteria, which should, where necessary, be supplemented by guidance notes to facilitate their application.

(27) In particular, the Commission should be empowered to adopt the amendments necessary to adapt Annexes II, III, IV and V to technical progress, and to adapt Annex II, Part C. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(28) The new elements introduced into this Directive concern only the committee procedures. They therefore do not need to be transposed by the Member States.

(29) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B,

This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.

Article 2

(i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;

(ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification;

(c) «contained use» means any activity in which microorganisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment;

(d) «accident» means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;

(e) «user» means any natural or legal person responsible for the contained use of GMMs;

(f) «notification» means the presentation of the requisite information to the competent authorities of a Member State.

1. Without prejudice to Article 4(1), this Directive shall not apply:

(a) where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A; or

(b) for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety for human health and the environment. These types of GMMs shall be listed in Annex II, Part C.

2. Article 4(3) and (6) and Articles 5 to 11 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air.

3. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in that Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.

1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs.

2. To that end, the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose, using as a minimum the elements of assessment and the procedure set out in Annex III, Sections A and B.

3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 5:

Class 1: activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health and the environment.

Class 2: activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health and the environment.

Class 3: activities of moderate risk, that is to say activities for which level 3 containment is appropriate to protect human health and the environment.

Class 4: activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health and the environment.

4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless, by agreement with the competent authority, there is sufficient evidence to justify the application of less stringent measures.

5. The assessment referred to in paragraph 2 shall especially take into account the question of disposal of waste and effluents. Where appropriate, the safety measures needed in order to protect human health and the environment shall be implemented.

6. A record of the assessment referred to in paragraph 2 shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 6, 8 and 9 or on request.

1. Save to the extent that point 2 of Annex IV allows other measures to be applied, the user shall apply the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured.

2. The assessment referred to in Article 4(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if:

(a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct; or

(b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge.

Article 6

When premises are to be used for the first time for contained uses, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A.

Article 7

1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part B shall be submitted.

2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification.

However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification.

3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority.

Article 9

1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part C shall be submitted.

Article 10

1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 6, 8 and 9.

2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 4(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures.

3. If necessary, the competent authority may:

(a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, should not begin, or, if in progress, should be suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;

(b) limit the time for which the contained use should be permitted or subject it to certain specific conditions.

4. For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time during which the competent authority:

Article 11

1. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences in terms of the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8 and 9 shall be modified.

2. If information subsequently becomes available to the competent authority which could have significant consequences in terms of the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use.

Article 12

Where a Member State considers it appropriate, it may provide that the public is to be consulted on aspects of the proposed contained use, without prejudice to Article 18.

Article 13

1. The competent authorities shall ensure that before a contained use commences:

(a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation;

(b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available.

2. The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals.

Article 14

(b) the identity and quantities of the GMMs concerned;

(c) any information necessary to assess the effects of the accident on the health of the general population and the environment;

(d) the measures taken.

2. Where information is given pursuant to paragraph 1, the Member States shall be required to:

(a) ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident;

(b) collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof.

(a) consult with other Member States likely to be affected in the event of an accident on the proposed implementation of emergency plans;

(b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations designed to limit its effects and to avoid similar accidents in the future.

2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.

Article 17

1. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 9, including the description, purpose and risks of the contained use(s).

2. Every three years, and for the first time on 5 June 2003, Member States shall send the Commission a summary report on their experience with this Directive.

3. Every three years, and for the first time on 5 June 2004, the Commission shall publish a summary based on the reports referred to in paragraph 2.

4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user.

1. Where its disclosure affects one or more of the items mentioned in Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information <*>, the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases.

<*> OJ L 41, 14.2.2003, p. 26.

The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.

2. In no case may the following information, when submitted pursuant to Articles 6, 8 or 9, be kept confidential:

(a) the general characteristics of the GMMs, the name and address of the notifier, and the location of use;

(b) the class of contained use and the containment measures;

(c) the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.

3. The Commission and the competent authorities shall not divulge to third parties any information deemed to be confidential according to the second subparagraph of paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received.

4. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.

Article 19

The measures designed to amend non-essential elements of this Directive relating to adapting Annexes II, III, IV and V to technical progress, and to adapting Annex II, Part C, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(2).

2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. 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.

Article 21

Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VII.

Article 22

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Done at Strasbourg, 6 May 2009.

Annex I

Part A

Techniques of genetic modification referred to in point (b)(i) of Article 2 are, inter alia:

1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.

2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the microorganism, including micro-injection, macro-injection and micro-encapsulation.

3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

1. in vitro fertilisation;

2. natural processes such as: conjugation, transduction, transformation;

3. polyploidy induction.

Techniques or methods of genetic modification yielding micro-organisms to be excluded from this Directive on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below:

1. Mutagenesis.

2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes.

Part B

Criteria establishing the safety of GMMs for human health and the environment

This Annex describes in general terms the criteria to be met when establishing the safety of types of GMMs for human health and the environment and their suitability for inclusion in Part C. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex.

1. Introduction

Types of GMMs listed in Part C in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) are excluded from the scope of this Directive. GMMs will be added to the list on a case-by-case basis and exclusion will relate only to each clearly identified GMM. This exclusion applies only when the GMM is used under conditions of contained use as defined in point (c) of Article 2. It does not apply to the deliberate release of GMMs. For a GMM to be listed in Part C, it must be proved that it meets the criteria given below.

Where any instability could adversely affect safety, evidence of stability is required.

3. Specific criteria

The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be:

3.1.1 Non-toxigenic

The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties.

3.1.2 Non-allergenic

The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM, that could cause harm to human health and the environment.

The modified genetic material must not give rise to harm if transferred; nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism.

GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur.

GMMs that do not meet the above criteria may not be included in Part C.

... (to be completed in accordance with the regulatory procedure with scrutiny referred to in Article 20(2))

Annex III

This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 4(2). Technical guidance notes <*> may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex, in particular as regards Section B.

<*> See Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III to Directive 90/219/EEC on the contained use of genetically modified micro-organisms (OJ L 258, 12.10.2000. p. 43).

A. Elements of assessment

1. The following should be considered as potentially harmful effects:

• disease to humans, including allergenic or toxic effects,
• disease to animals or plants,

(iii) the vector;

(iv) the donor micro-organism (as long as the donor micro-organism is used during the operation);

(v) the resulting GMM;

(b) the characteristics of the activity;

(c) the severity of the potentially harmful effects;

(d) the likelihood of the potentially harmful effects being realised.

B. Procedure

3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, and any harmful properties associated with the vector or inserted material, including any alteration in the recipient's existing properties.

4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 4(3):

(i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants <*>;

<*> This would only apply to animals and plants in the environment likely to be exposed.

(ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants <*>, or likely to have deleterious effects on the environment;

<*> This would only apply to animals and plants in the environment likely to be exposed.

(iii) the GMM is unlikely to cause disease to humans, animals or plants <*> and is unlikely to have deleterious effects on the environment.

<*> This would only apply to animals and plants in the environment likely to be exposed.

5. In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Directive 2000/54/EC). International or national classification schemes (e.g. World Health Organisation, National Institutes of Health) and their revisions due to new scientific knowledge and technical progress may also be considered.

These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 2000/54/EC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance for the purposes of categorisation of the contained use activities in the four classes of risk referred to in Article 4(3). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures.

6. The hazard identification process carried out in accordance with points 3 to 5 should lead to the identification of the level of risk associated with the GMM.

7. Selection of the containment and other protective measures should then be made on the basis of the level of risk associated with the GMMs together with consideration of:

(i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity);

(ii) the characteristics of the activity (e.g. its scale and/or nature);

(iii) any non-standard operations (e.g. the inoculation of animals with GMMs; use of equipment likely to generate aerosols).

Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under point 6.

8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 4(3).

9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 4(2).

Annex IV

1. These tables present the normal minimum requirements and measures necessary for each level of containment.

Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply:

(i) to keep workplace and environmental exposure to any GMM to the lowest practicable level;

(ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;

(vi) to establish biological safety committees or subcommittees, if required;

(vii) to formulate and implement local codes of practice for the safety of personnel, as required;

(viii) where appropriate, to display biohazard signs;

(ix) to provide washing and decontamination facilities for personnel;

(x) to keep adequate records;

(xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;

(xii) to prohibit mouth pipetting;

(xiii) to provide written standard operating procedures where appropriate to ensure safety;

(xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;

(xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate.

2. The titles of the tables are indicative:

Table I A presents minimum requirements for laboratory activities.

Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.

Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs.

Table II presents minimum requirements for activities other than laboratory activities.

In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level.

In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels.

In these tables «optional» means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2).

3. In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements.

Table I A

Containment and other protective measures for laboratory activities

The terms «glasshouse» and «growth-room» refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.

All provisions of Table I A shall apply with the following additions/modifications:

Containment and other protective measures for activities in animal units

All provisions of Table I A shall apply with the following additions/modifications:

Table II

Annex V

Part A

Information required for the notification referred to in Article 6:

• name of user(s), including those responsible for supervision and safety,
• information on the training and qualifications of the persons responsible for supervision and safety,
• details of any biological committees or subcommittees,
• address and general description of the premises,
• a description of the nature of the work which will be undertaken,
• the class of the contained uses,
• only for class 1 contained uses, a summary of the assessment referred to in Article 4(2) and information on waste management.

Part B

Information required for the notification referred to in Article 8:

• the date of submission of the notification referred to in Article 6,
• the names of the persons responsible for supervision and safety and information on their training and qualification,
• the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used,
• the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s),
• the identity and characteristics of the GMM,
• the purpose of the contained use, including the expected results,
• the approximate culture volumes to be used,
• a description of the containment and other protective measures to be applied, including information about waste management, including the wastes to be generated, their treatment, final form and destination,

• the source(s) and intended function(s) of the genetic material(s) involved in the modification(s),
• the identity and characteristics of the GMM,
• the culture volumes to be used;

(c) — a description of the containment and other protective measures to be applied, including information about waste management, including the type and form of wastes to be generated, their treatment, final form and destination,

• the purpose of the contained use, including the expected results,
• a description of the parts of the installation;

(d) information about accident prevention and emergency response plans, if any:

• any specific hazards arising from the location of the installation,
• the preventive measures applied, such as safety equipment, alarm systems and containment methods,
• the procedures and plans for verifying the continuing effectiveness of the containment measures,
• a description of information provided to workers,
• the information necessary for the competent authority to evaluate any emergency response plans, if required under Article 13(1);

(e) a copy of the assessment referred to in Article 4(2).

Annex VI

Part A

Repealed Directive with list of its successive amendments (referred to in Article 21)

Part B

Annex VII