Regulation (EC) No 1829/2003 of the European Parliament and of the CouncilShow full title

CHAPTER IV U.K. COMMON PROVISIONS

Article 27 U.K. Products likely to be used as both food and feed

1. Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

2. The Authority shall consider whether the application for authorisation should be submitted both as food and feed.

Article 28 U.K. Community register

1. The Commission shall establish and maintain a Community register of genetically modified food and feed, hereinafter referred to as ‘the Register’.

2. The Register shall be made available to the public.

Article 29 U.K. Public access

1. The application for authorisation, supplementary information from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC, monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.

2. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(1) when handling applications for access to documents held by the Authority.

3. Member States shall handle applications for access to documents received under this regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

Article 30 U.K. Confidentiality

1. The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.

2. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.

3. Information relating to the following shall not be considered confidential:

(a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indication of the substrate and the micro-organism;

(b) general description of the GMO and the name and address of the authorisation-holder;

(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);

(d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment;

(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;

(f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);

(g) information on waste treatment and emergency response.

4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.

5. The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.

6. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

7. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Commission and the applicant disagree.

Article 31 U.K. Data protection

The scientific data and other information in the application dossier required under Article 5(3) and (5) and Article 17(3) and (5) may not be used for the benefit of another applicant for a period of 10 years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.

On the expiry of this 10-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if the applicant can demonstrate that the food or feed for which it is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 32 U.K. Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those referred to in the Annex.

National reference laboratories may be established in accordance with the procedure referred to in Article 35(2).

Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the Community reference laboratory and the European Network of GMO laboratories mentioned in the Annex.

The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.

[F1 Detailed rules for implementing this Article and the Annex may be adopted in accordance with the regulatory procedure referred to in Article 35(2).

Measures designed to amend non-essential elements of this Regulation and adapting the Annex shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).]

Textual Amendments

F1 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.

Article 33 U.K. Consultation with the European Group on Ethics in Science and New Technologies

1. The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies or any other appropriate body it might establish, with a view to obtaining its opinion on ethical issues.

2. The Commission shall make these opinions available to the public.

Article 34 U.K. Emergency measures

Where it is evident that products authorised by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the procedures provided for in Articles 53 and 54 of Regulation (EC) No 178/2002.

Article 35 U.K. Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as the ‘Committee’.

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

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

[F1 3. 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.]

Textual Amendments

F1 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.

Article 36 U.K. 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 take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

Article 37 U.K. Repeals

The following Regulations shall be repealed with effect from the date of application of this Regulation:

• Regulation (EC) No 1139/98,

• Regulation (EC) No 49/2000,

• Regulation (EC) No 50/2000.

Article 38 U.K. Amendments to Regulation (EC) No 258/97

Regulation (EC) No 258/97 is hereby amended with effect from the date of application of this Regulation as follows:

1.

The following provisions shall be deleted:

• Article 1(2)(a) and (b),

• Article 3(2), second subparagraph, and (3),

• Article 8(1)(d),

• Article 9.

2.

In Article 3, the first sentence of paragraph 4 shall be replaced by the following:

‘4. By way of derogation from paragraph 2, the procedure referred to in Article 5 shall apply to foods or food ingredients referred to in Article 1(2)(d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4(3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.’

Article 39 U.K. Amendment to Directive 82/471/EEC

The following paragraph shall be added to Article 1 of Directive 82/471/EEC with effect from the date of application of this Regulation:

‘3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(2).’

Article 40 U.K. Amendments to Directive 2002/53/EC

Directive 2002/53/EC is hereby amended with effect from the date of application of this Regulation as follows:

1.

Article 4(5) shall be replaced by the following:

‘5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(3), the variety shall be accepted only if it has been approved in accordance with that Regulation.’

2.

Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety(4) is accepted only if it has been authorised under the relevant legislation.’

Article 41 U.K. Amendments to Directive 2002/55/EC

Directive 2002/55/EC is hereby amended with effect from the date of application of this Regulation as follows:

1.

Article 4(3) shall be replaced by the following:

‘3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or in feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(5), the variety shall be accepted only if it has been approved in accordance with that Regulation.’

2.

Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety(6) is accepted only if it has been authorised under the relevant legislation.’

Article 42 U.K. Amendment to Directive 68/193/EEC

Article 5ba(3) of Directive 68/193/EEC shall be replaced by the following wording with effect from the date of application of this Regulation:

‘3. (a) Where products derived from vine-propagating material are intended to be used as or in food falling within the scope of Article 3 or as or in a feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(7), the vine variety concerned shall be accepted only if it has been authorised pursuant to the said Regulation.

(b) Member States shall ensure that a vine variety, from the propagating material of which products were derived intended for use in food and feed pursuant to Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety(8) shall be accepted only if it has been authorised pursuant to the relevant legislation.’

Article 43 U.K. Amendments to Directive 2001/18/EC

Directive 2001/18/EC is hereby amended with effect from the date of entry into force of this Regulation, as follows:

1.

The following Article shall be inserted:

‘Article 12a Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

1. Placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to 21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(9).

2. This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.’

2.

The following Article shall be inserted:

‘Article 26a Measures to avoid the unintended presence of GMOs

1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

Article 44 U.K. Information to be provided in accordance with the Cartagena Protocol

1. Any authorisation, renewal, modification, suspension or revocation of authorisation of a GMO, food or feed referred to in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by the Commission to the Parties to the Cartagena Protocol through the biosafety clearing house in accordance with Article 11(1) or Article 12(1) of the Cartagena Protocol, as the case may be.

The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the biosafety clearing house.

2. The Commission shall also process requests for additional information made by any Party in accordance with Article 11(3) of the Cartagena Protocol and shall provide copies of the laws, regulations and guidelines in accordance with Article 11(5) of that Protocol.

Article 45 U.K. Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission six months after the date of entry into force of this Regulation at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 46 U.K. Transitional measures for requests, labelling and notifications

1. Requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97. Other requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97, notwithstanding Article 38 of this Regulation.

2. The labelling requirements referred to in this Regulation shall not apply to products, the manufacturing process of which has commenced before the date of application of this Regulation, provided that these products are labelled in accordance with the legislation applicable to them before the date of application of this Regulation.

3. Notifications concerning products including their use as feed submitted under Article 13 of Directive 2001/18/EC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for in Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.

4. Requests submitted for products referred to in Article 15(1)(c) of this Regulation under Article 7 of Directive 82/471/EEC before the date of application of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.

5. Requests submitted for products referred to in Article 15(1) of this Regulation under Article 4 of Directive 70/524/EEC before the date of application of this Regulation shall be supplemented by applications under Chapter III, Section 1 of this Regulation.

Article 47 U.K. Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation

1. The presence in food or feed of material which contains, consists of or is produced from GMOs in a proportion no higher than 0,5 % shall not be considered to be in breach of Article 4(2) or Article 16(2), provided that:

(a) this presence is adventitious or technically unavoidable;

(b) the genetically modified material has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before the date of application of this Regulation;

(c) the application for its authorisation has not been rejected in accordance with the relevant Community legislation; and

(d) detection methods are publicly available.

2. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of such materials.

[F1 3. Measures designed to amend non-essential elements of this Regulation by supplementing it and lowering the thresholds referred to in paragraph 1, in particular for GMOs sold directly to the final consumer, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).]

4. Detailed rules for implementing this Article shall be adopted in accordance with the procedure referred to in Article 35(2).

5. This Article shall remain applicable for a period of three years after the date of application of this Regulation.

Textual Amendments

F1 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.

Article 48 U.K. Review

1. No later than 7 November 2005 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Article 47, accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.

2. Without prejudice to the powers of national authorities, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 49 U.K. Entry into force

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

It shall apply from six months after the date of publication of this Regulation.

(1)

OJ L 145, 31.5.2001, p. 43.

(2)

OJ L 268, 18.10.2003, p. 1.

(3)

OJ L 268, 18.10.2003, p. 1.

(4)

OJ L 31, 1.2.2002, p. 1.

(5)

OJ L 268, 18.10.2003, p. 1.

(6)

OJ L 31, 1.2.2002, p. 1.

(7)

OJ L 268, 18.10.2003, p. 1.

(8)

OJ L 31, 1.2.2002, p. 1.

(9)

OJ L 268, 18.10.2003, p. 1.