Artikelen bij COM(2023)411 - Met bepaalde nieuwe genomische technieken verkregen planten en de daarvan afgeleide levensmiddelen en diervoeders

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dossier COM(2023)411 - Met bepaalde nieuwe genomische technieken verkregen planten en de daarvan afgeleide levensmiddelen en diervoeders.
document COM(2023)411 EN
datum 5 juli 2023

Inhoudsopgave

CHAPTER I - GENERAL PROVISIONS

Article 1 - Subject matter

This Regulation lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by certain new genomic techniques (‘NGT plants’) and for the placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants.

Article 2 - Scope

This Regulation shall apply to:

(1)NGT plants;

(2)food containing, consisting of or produced from NGT plants, or containing ingredients produced from NGT plants; 

(3)feed containing, consisting or produced from NGT plants;

(4)products, other than food and feed, containing or consisting of NGT plants.

Article 3 - Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)the definitions of ‘organism’, ‘deliberate release’ and ‘placing on the market’ set out in Directive 2001/18/EC, those of ‘food’ and ‘feed’ set out in Regulation (EC) No 178/2002, that of ‘traceability’ set out in Regulation (EC) No 1830/2003, that of ‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council( 58 ) and that of ‘plant reproductive material’ set out in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union 59 ];

(2)‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant;

(3)‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;

(4)‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism;

(5)‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool;

(6)‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;

(7)‘category 1 NGT plant’ means a NGT plant that:

(a)fulfils the criteria of equivalence to conventional plants, set out in Annex I, or

(b)is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;

(8)‘category 2 NGT plant’ means a NGT plant other than a category 1 NGT plant;

(9)‘NGT plant for food use’ means a NGT plant that may be used as food or as a source material for the production of food; 

(10)‘NGT plant for feed use’ means a NGT plant that may be used as feed or as a source material for the production of feed;

(11)‘produced from a NGT plant’ means derived, in whole or in part, from a NGT plant, but not containing or consisting of a NGT plant;

(12)‘NGT product’ means a product, other than food and feed, containing or consisting of a NGT plant and food and feed containing, consisting of or produced from such a plant;

(13)‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

(14)‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

(15)‘small or medium sized enterprise (SME)’ means a SME within the meaning of Commission Recommendation 2003/361/EC2.

Article 4 - Deliberate release of NGT plants for any other purpose than placing on the market and placing on the market of NGT products

Without prejudice to other requirements of Union law, a NGT plant may only be deliberately released into the environment for any other purpose than placing on the market, and a NGT product may only be placed on the market, if:

(1)the plant is a category 1 NGT plant and

(a)has obtained a decision declaring that status in accordance with Article 6 or 7; or

(b)is progeny of plant(s) referred to in point (a); or

(2)the plant is a category 2 NGT plant and has been authorised in accordance with Chapter III.

CHAPTER II - Category 1 NGT plants and category 1 NGT products

Article 5 - Status of category 1 NGT plants

1.The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants.

2.For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and 11 shall apply to category 1 NGT plants and to products produced from or by such plants.

3.The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.

Article 6 - Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market

1.To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I are met (‘verification request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementing act adopted in accordance with Article 27, point (b).

2.Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of those Member States.

3.The verification request referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

(a)the name and the address of the requester;

(b)the designation and specification of the NGT plant;

(c)a description of the trait(s) and characteristics which have been introduced or modified;

(d)a copy of the studies, which have been carried out and any other available material to demonstrate that:

(i)the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(ii)the NGT plant meets the criteria set out in Annex I;

(e)in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

(f)an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

4.The competent authority shall acknowledge receipt of the verification request to the requester without undue delay, stating the date of receipt. It shall make available the request to the other Member States and to the Commission without undue delay.

5.If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

6.If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

7.The other Member States and the Commission may make comments to the verification report within 20 days from the date of receipt of that report.

8.In the absence of any comments from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

9.In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the the comment(s) to the Commission without undue delay.

10.The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

11.The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union.

Article 7 - Verification procedure of category 1 NGT plant status prior to the placing on the market of NGT products

1.Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).

2.The verification request referred to in paragraph 1 shall be submitted to the Authority in accordance with standard data formats, where they exist, pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

(a)the name and the address of the requester;

(b)the designation and specification of the NGT plant;

(c)a description of the trait(s) and characteristics which have been introduced or modified;

(d)a copy of the studies, which have been carried out and any other available material to demonstrate that:

(i)the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(ii)the NGT plant meets the criteria set out in Annex I;

(e)an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

3.The Authority shall acknowledge receipt of the verification request to the requester without delay, stating the date of receipt. It shall make available the verification request to the Member States and to the Commission without undue delay and make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

4.If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

5.If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

6.The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

7.The Commission shall publish a summary of the decision in the Official Journal of the European Union.

Article 8 - System of exchange of information between Member States, the Commission and the Authority

The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

Article 9 - Database of decisions declaring the category 1 NGT plant status

1.The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6). 

The database shall contain the following information:

(a)name and the address of the requester;

(b)the designation of the category 1 NGT plant;

(c)a summarised description of the technique(s) used to obtain the genetic modification;

(d)a description of the trait(s) and characteristics which have been introduced or modified;

(e)an identification number, and

(f)the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

2.The database shall be publicly available.

Article 10 - Labelling of category 1 NGT plant reproductive material, including breeding material

Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.

Article 11 - Confidentiality

1.The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.

2.The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

3.The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree:

(a)items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

(b)DNA sequence information; and

(c)breeding patterns and strategies.

4.The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision.

5.Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6.The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

7.In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

CHAPTER III - Category 2 NGT plants and category 2 NGT products

Article 12 - Status of Category 2 NGT plants and category 2 NGT products

The rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.

SECTION - 1


Deliberate release of category 2 NGT plants for any other purpose than for placing on the market

Article 13 - Content of the notification referred in Article 6 of Directive 2001/18/EC

As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

(a)the name and the address of the notifier;

(b)a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(c)a technical dossier supplying the information specified in Annex II necessary to carry out the environmental risk assessment of the deliberate release of a NGT plant or combination of NGT plants:

(i)general information including information on personnel and training;

(ii)information relating to the category 2 NGT plant(s);

(iii)information relating to the conditions of release and the potential receiving environment;

(iv)information on the interactions between the category 2 NGT plant(s) and the environment;

(v)a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;

(vi)where relevant, information on control, remediation methods, waste treatment and emergency response plans;

(vii)an identification of the parts of the notification and any other supplementary information that the notifier requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 25 of Directive 2001/18;

(viii)a summary of the dossier;

(d)the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c).

SECTION - 2


Placing on the market of category 2 NGT products other than food or feed

Article 14 - Content of the notification referred to in Article 13 of Directive 2001/18/EC

1.As regards the placing on the market of category 2 NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

(a)name and address of the notifier and of its representative established in the Union (if the notifier is not established in the Union); 

(b)designation and specification of the category 2 NGT plant;

(c)scope of the notification:

(i)cultivation;

(ii)other uses (to be specified in the notification);

(d)a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(e)the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

(f)the conditions for the placing on the market of the product, including specific conditions of use and handling;

(g)with reference to Article 15(4) of Directive 2001/18/EC, a proposed period for the consent, which should not exceed 10 years;

(h)where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifier considers that the NGT plant does not need a monitoring plan, the notifier may propose not to submit a monitoring plan;

(i)a proposal for labelling which shall comply with the requirements laid down in point A.8. of Annex IV to Directive 2001/18/EC, Article 4(6) of Regulation (EC) No 1830/2003 and Article 23 of this Regulation;

(j)proposed commercial names of the products and names of category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 ( 60 ). After the consent any new commercial names should be provided to the competent authority;

(k)description of how the product is intended to be used. Differences in use or management of that product compared to similar non-genetically modified products shall be highlighted;

(l)methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2); 

(m)samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

(n)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;

(o)an identification of the parts of the notification and any other supplementary information that the notifier requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 25 of Directive 2001/18/EC and Articles 39 to 39e of Regulation (EC) No 178/2002;

(p)a summary of the dossier in a standardised form.

2.The notifier shall include in this notification information on data or results from releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

3.The competent authority that prepares the assessment report referred to in Article 14 of Directive 2001/18/EC shall examine the notification for compliance with paragraphs 1 and 2.

Article 15 - Specific provisions on monitoring

The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.

Article 16 - Labelling in accordance with Article 23

In addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.

Article 17 - Duration of the validity of the consent after renewal

1.The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.

2.The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

SECTION - 3


Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed

Article 18 - Scope

This Section shall apply to:

(a)category 2 NGT plants for food use or for feed use;

(b)food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);

(c)feed containing, consisting or produced from category 2 NGT plants (‘category 2 NGT feed’).

Article 19 - Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003

1.By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

(a)the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

(b)the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety assessment of the food or feed carried out in accordance with the principles and criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).

2.By way of derogation from Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

3.By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants or food or feed containing or consisting of category 2 NGT plants, the application shall also be accompanied by:

(a)the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

(b)where appropriate, a monitoring plan for environmental effects in accordance 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 duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit a monitoring plan.

4.The application shall also contain a proposal for labelling in accordance with Article 23.

Article 20 - Specific provisions on the opinion of the Authority

1.By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.

Where the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the safety assessment of the food or feed pursuant to Article 6(3), points (b) and (c) and Article 18(3), points (b) and (c) of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the national competent authority through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the six months period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.

2.In addition to the tasks referred to in Article 6(3) and Article 18(3) of Regulation (EC) No 1829/2003, the Authority shall verify whether all the particulars and documents submitted by the applicant are in conformity with Article 19 of this Regulation.

3.By way of derogation from Article 6(3), point (d), and Article 18(3), point (d), of Regulation (EC) No 1829/2003, the Authority shall forward to the Union reference laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 the particulars referred to in Article 19(2) of this Regulation and in Article 5(3), point (j), and Article 17(3), point (j), of Regulation (EC) No 1829/2003.

4.The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph.

5.By way of derogation from Article 6(5), point (f), and Article 18(5), point (f), of Regulation (EC) No 1829/2003, in the event of an opinion in favour of authorising the food or the feed, the opinion shall also include:

(a)the method, validated by the Union reference laboratory, for detection, including sampling, and, where applicable, identification and quantification of the NGT plant and detection and identification of the NGT plant in the NGT food or feed, and a justification of any adaptation of the method in the cases referred to in Article 19(2), subparagraph 2;

(b)an indication of where appropriate reference material can be accessed.

6.In addition to the particulars mentioned in Article 6(5), point (d) and Article 18(5), point (d) of Regulation (EC) No 1829/2003, the opinion shall also include a proposal for labelling in accordance with Article 23 of this Regulation.

Article 21 - Duration of the validity of the authorisation after renewal

By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.

SECTION - 4


Common provisions for category 2 NGT plants and category 2 NGT products

Article 22 - Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability

1.The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex III and it does not have any traits referred to in Part 2 of that Annex. 

2.The following incentives shall apply to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

(a)by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

(b)where the applicant is a SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

3.The following pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex II shall, in addition to Article 32a of Regulation (EC) No 178/2002, apply prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

(a)the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

(b)where the potential applicant or notifier is a SME, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

4.The pre-submission advice referred to in paragraph 3 shall comply with the following requirements:

(a)it shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Panel on Genetically Modified Organisms of the Authority. The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice;

(b)for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 concerning a category 2 NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration with the competent authority of the Member State to which the notification or application is going to be submitted;

(c)the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

(d)potential applicants or notifiers demonstrating that they are a SME can request the pre-submission advice referred to in paragraph 3, point (a), at different points in time.

5.Any request for the incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 or the application referred to in Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19, and accompanied by the following information:

(a)the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME; 

(c)for the purpose of paragraph 3, information on the aspects listed in Part 1 of Annex II as far as it can already be provided and any other relevant information.

6.Article 26 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 shall apply to information submitted under this article to the Authority, as appropriate.

7.The Authority shall lay down the practical arrangements to implement paragraphs (3) to (6).

8.The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

(a)the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3);

(b)the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability of the trait(s) it intends to add to or delete from the list in Annex III;

(c)where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.

Article 23 - Labelling of authorised category 2 NGT products

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.

Article 24 - Measures to avoid the unintended presence of category 2 NGT plants

Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Article 25 - Cultivation

Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

CHAPTER IV - FINAL PROVISIONS

Article 26 - Exercise of the delegation

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

2.The power to adopt the delegated acts referred to in Article 5(3) and Article 22(8) shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-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 3 months before the end of each period.

3.The delegations of power referred to in Article 5(3) and Article 22(8) 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.

4.Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making( 61 ).

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 Articles Article 5(3) and Article 22(8) 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 of 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 2 months at the initiative of the European Parliament or of the Council.

Article 27 - Implementing acts

The Commission shall adopt implementing acts concerning:

(a)the information required to demonstrate that a plant is a NGT plant;

(b)the preparation and the presentation of the verification requests referred to in Articles 6 and 7;

(c)the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

(d)the application of Articles 14 and 19, including rules concerning the preparation and the presentation of the notification or application;

(e)adapted modalities to comply with analytical method requirements referred to in Article 14(1), point (l), and Article 19(2).

Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

Article 28 - Committee procedure

1.The Commission shall be assisted by the committee set up by Article 58 of Regulation (EC) No 178/2002.

2.Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

3.Where reference is made to this paragraph, Article 5 of Regulation (EC) No 182/2011 shall apply.

Article 29 - Guidance

1.Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the notifier or the applicant in the preparation and the presentation of the notifications and the application referred to in Chapters II and III and for the implementation of Annex II.

2.Before the date of application of this Regulation, the European Union Reference Laboratory for Genetically Modified Food and Feed established pursuant to Article 32 of Regulation (EC) No 1829/2003, assisted by the European Network of GMO Laboratories, shall publish detailed guidance to assist the notifier or the applicant for the application of Article 14(1), point (l), and Article 19(2).

Article 30 - Monitoring, reporting and evaluation

1.No sooner than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

2.The report shall also address any ethical issues that have arisen with the application of this Regulation.

3.For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

4.No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market, and economic, environmental and social sustainability.

5.The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Article 31 - References in other Union legislation

With regard to category 2 NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.

Article 32 - Administrative review

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

The Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Article 33 - Amendments to Regulation (EU) 2017/625

Article 23 of Regulation (EU) 2017/625 is amended as follows:

(1)in paragraph 2, point (a)(ii) is replaced by the following:

‘(ii)the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];’;

(2)in paragraph 3, point (b) is replaced by the following:

‘(b)the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];’.

Article 34 - Entry into force and application

1.This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.It shall apply from [24 months from the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.