CHAPTER II

GENETICALLY MODIFIED FOOD
Section 1

Authorisation and supervision

Scope
Article 3
1
This Section shall apply to:
a
GMOs for food use;
b
food containing or consisting of GMOs;
c
food produced from or containing ingredients produced from GMOs.
2
Where necessary, measures designed to amend non-essential elements of this Regulation by supplementing it and determining whether a type of food falls within the scope of this Section shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).

Requirements
Article 4
1
Food referred to in Article 3(1) must not:
a
have adverse effects on human health, animal health or the environment;
b
mislead the consumer;
c
differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.
2
No person shall place on the market a GMO for food use or food referred to in Article 3(1) unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are satisfied.
3
No GMO for food use or food referred to in Article 3(1) shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1 of this Article.
4
The authorisation referred to in paragraph 2 may cover:
a
a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or
b
food produced from a GMO as well as foods produced from or containing that food;
c
an ingredient produced from a GMO as well as food containing that ingredient.
5
An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
6
The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder or his representative, shall be established in the Community.
7
Authorisation under this Regulation shall be without prejudice to Directive 2002/53/EC, Directive 2002/55/EC and Directive 68/193/EEC.

Application for authorisation
Article 5
1
To obtain the authorisation referred to in Article 4(2), an application shall be submitted in accordance with the following provisions.
2
The application shall be sent to the national competent authority of a Member State.
a
The national competent authority:
1. shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;
2. shall inform without delay the European Food Safety Authority (hereinafter referred to as the Authority); and
3. shall make the application and any supplementary information supplied by the applicant available to the Authority.
b
The Authority
1. shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
2. shall make the summary of the dossier referred to in paragraph 3(1) available to the public.
3
The application shall be accompanied by the following:
a
the name and the address of the applicant;
b
the designation of the food, and its specification, including the transformation event(s) used;
c
where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);
d
where applicable, a detailed description of the method of production and manufacturing;
e
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4(1);
f
either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3);
g
either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b);
h
where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;
i
methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
j
samples of the food and their control samples, and information as to the place where the reference material can be accessed;
k
where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;
l
a summary of the dossier in a standardised form.
4
In the case of an application relating to a GMO for food use, references to ‘food’ in paragraph 3 shall be interpreted as referring to food containing, consisting of or produced from the GMO in respect of which an application is made.
5
In the case of GMOs or food containing or consisting of GMOs, the application shall also be accompanied by:
a
the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
b
a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.
6
Where the application concerns a substance, the use and placing on the market of which is subject, under other provisions of Community law, to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
7
The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.
8
Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

Opinion of the Authority
Article 6
1
In giving its opinion, the Authority shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
2
The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
3
In order to prepare its opinion the Authority:
a
shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);
b
may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/2002;
c
may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;
d
shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant;
e
shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
4
In the case of GMOs or food containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/EC designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.
5
In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:
a
the name and address of the applicant;
b
the designation of the food, and its specification;
c
where applicable, the information required under Annex II to the Cartagena Protocol;
d
the proposal for the labelling of the food and/or foods produced from it;
e
where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, conditions for the protection of particular ecosystems/environment and/or geographical areas;
f
the method, validated by the Community reference laboratory, for detection, including sampling, identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it; an indication of where appropriate reference material can be accessed;
g
where appropriate, the monitoring plan referred to in Article 5(5)(b).
6
The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.
7
The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.

Authorisation
Article 7
1
Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred in Article 35 a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
2
Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 6(5), the name of the authorisation-holder and, where appropriate, the unique identifier attributed to the GMO as referred to in the Regulation (EC) No 1830/2003.
3
A final decision on the application shall be adopted in accordance with the procedure referred to in Article 35(2).
4
The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.
5
The authorisation granted in accordance with the procedure referred to in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 11. The authorised food shall be entered in the Register referred to in Article 28. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.
6
The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.
7
The granting of authorisation shall not lessen the general civil and criminal liability of any food operator in respect of the food concerned.
8
References made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Status of existing products
Article 8
1
By way of derogation from Article 4(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:
a
in the case of products placed on the market under Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions referred to in Regulation (EC) No 258/97, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;
b
in the case of products which have been lawfully placed on the market in the Community but are not covered by point (a), operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.
2
The notification referred to in paragraph 1 shall be accompanied by the particulars mentioned in Article 5(3) and (5), as appropriate, which the Commission shall forward to the Authority and the Member States. The Authority shall forward to the Community reference laboratory the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant.
3
Within one year from the date of application of this Regulation and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. Each entry in the Register shall include the particulars referred to in Article 7(2) as appropriate and, in the case of the products referred to in paragraph 1(a), shall mention the date on which the products concerned were first placed on the market.
4
Within nine years from the date on which the products referred to in paragraph 1(a) were first placed on the market, but in no case earlier than three years after the date of application of this Regulation, operators responsible for placing them on the market shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.
Within three years from the date of application of this Regulation, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.
5
Products referred to in paragraph 1 and food containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 9, 10 and 34, which shall apply mutatis mutandis.
6
Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 4 within the period specified, the Commission, acting in accordance with the procedure referred to in Article 35(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.
7
In the case of authorisations not issued to a specific holder, the operator who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to Commission.
8
Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

Supervision
Article 9
1
After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article 30.
2
If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 5(2). Articles 5, 6 and 7 shall apply mutatis mutandis.
3
The authorisation-holder shall forthwith inform the Commission of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Commission of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.
4
The Commission shall make the information supplied by the applicant available to the Authority and the Member States without delay.

Modification, suspension and revocation of authorisations
Article 10
1
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation. It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States. The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.
2
The Commission shall examine the opinion of the Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure referred to in Article 7.
3
Articles 5(2), 6 and 7 shall apply mutatis mutandis.

Renewal of authorisations
Article 11
1
Authorisations under this Regulation shall be renewable for 10-year periods, on application to the Commission by the authorisation-holder at the latest one year before the expiry date of the authorisation.
2
The application shall be accompanied by the following:
a
a copy of the authorisation for placing the food on the market;
b
a report on the results of the monitoring, if so specified in the authorisation;
c
any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
d
where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.
3
Articles 5(2), 6 and 7 shall apply mutatis mutandis.
4
Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.
5
The Commission, having first consulted the Authority, may establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.
6
The Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.
Substituted by Regulation (EC) No 298/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 1829/2003 on genetically modified food and feed, as regards the implementing powers conferred on the Commission.