The Genetic Technology (Precision Breeding) Regulations 2025

Part 7 Food and feed produced from precision bred organisms

Interpretation of this Part

18.  In this Part—

“applicant” means a person who applies for a food and feed marketing authorisation(1) under regulation 20 or 22;

“authorisation-holder” means a person who has been issued a food and feed marketing authorisation under this Part;

“Food Standards Advisory Committee” means the Advisory Committee on Novel Foods and Processes or any advisory committee appointed under section 5(3) of the Food Standards Act 1999(2);

“representative” means a person, nominated by the applicant, who may be contacted in relation to the application for the food and feed marketing authorisation concerned.

Marketing of food and feed produced from precision bred organisms - requirement for authorisation

19.—(1) No person may place on the market(3) in England food or feed produced from a precision bred organism unless—

(a) a food and feed marketing authorisation in respect of the precision bred organism used to produce the food or feed has been issued by the Secretary of State under this Part,

(b) any conditions or limitations to which the food and feed marketing authorisation is subject are met, and

(c) the food and feed marketing authorisation has not been revoked.

(2) A precision bred organism under paragraph (1) must be—

(a) a marketable precision bred organism(4), or

(b) the qualifying progeny(5) of a marketable precision bred organism.

(3) A food and feed marketing authorisation in respect of a precision bred organism includes the authorisation of the qualifying progeny of that organism provided that any features of the qualifying progeny resulting from the application of modern biotechnology are inherited from—

(a) that precision bred organism, or

(b) another precision bred organism in respect of which a food and feed marketing authorisation is in force.

(4) Qualifying progeny are subject to all of the conditions and limitations of every food and feed marketing authorisation by virtue of which they are authorised under paragraph (3)(a) and, where it applies, paragraph (3)(b).

Application for a food and feed marketing authorisation

20.—(1) A person may apply for a food and feed marketing authorisation under this regulation if—

(a) the precision bred organism is an organism in respect of which a precision bred confirmation is in force(6);

(b) the person is able to demonstrate that the relevant precision bred organism belongs to a species that has a history of safe food use in accordance with paragraph (2);

(c) the person is able to demonstrate that the application of modern biotechnology to the precision bred organism does not introduce genetic changes that are expected to—

(i) significantly alter the nutritional quality of the organism as it is being consumed as food or feed at the date of the application in a way that is likely to be disadvantageous to the consumer;

(ii) significantly elevate the toxicity of any food or feed produced from the precision bred organism;

(iii) alter the allergenicity of any food or feed produced from the precision bred organism;

(iv) introduce any additional features that may affect the safety of any food or feed produced from the precision bred organism.

(2) In paragraph (1)(b), “history of safe food use” means that the safety of the species in question as food has been confirmed with compositional data and from experience of continued food use in the customary diet of a significant number of people in the United Kingdom or the European Union beginning before 15th May 1997.

(3) A person may apply to the Food Standards Agency for a food and feed marketing authorisation under this regulation by making an application containing the information specified in paragraph 1 of Schedule 4.

(4) The information provided pursuant to paragraph (3) must be sufficiently detailed to allow the Food Standards Agency to assess the application having regard to the nature and scale of the application.

(5) The application may be accompanied by any other information that the applicant considers relevant.

(6) If an applicant is not established in Great Britain, the applicant must appoint a representative who is established in Great Britain in the application.

(7) Upon receipt of an application under paragraph (1), the Food Standards Agency must, as soon as reasonably practicable—

(a) acknowledge receipt of the application;

(b) verify whether the application contains the information specified in paragraph 1 of Schedule 4 (as read with paragraph (4) of this regulation).

(8) If, notwithstanding any further information provided pursuant to regulation 24, the application does not contain the information specified in paragraph 1 of Schedule 4, the Food Standards Agency must advise the applicant that the application is invalid.

Requirement to report verified applications for a food and feed marketing authorisation under regulation 20 to the Secretary of State

21.  If an application under regulation 20 contains the information specified in paragraph 1 of Schedule 4, the Food Standards Agency must report that to the Secretary of State together with any other matters that the Food Standards Agency considers relevant to the issuing of a food and feed marketing authorisation.

Application for a food and feed marketing authorisation - where a Food Standards Agency assessment is required

22.—(1) A person may apply for a food and feed marketing authorisation under this regulation if—

(a) the precision bred organism is an organism in respect of which a precision bred confirmation is in force;

(b) the person reasonably concludes that—

(i) the precision bred organism does not belong to a species that has a history of safe food use as defined in regulation 20(2);

(ii) the application of modern biotechnology to the precision bred organism may introduce genetic changes such that any of paragraphs (i) to (iv) of regulation 20(1)(c) apply or might apply to the precision bred organism.

(2) A person may apply to the Food Standards Agency for a food and feed marketing authorisation under this regulation by making an application containing the information specified in Schedule 4.

(3) The information provided pursuant to paragraph (2) must be sufficiently detailed to allow the Food Standards Agency to assess the application having regard to the nature and scale of the application.

(4) If an applicant is not established in Great Britain, the applicant must appoint a representative who is established in Great Britain in the application.

(5) The application may be accompanied by—

(a) any previous application made under this Part by any other person provided that the agreement in writing of that other person is obtained;

(b) any other information that the applicant considers relevant.

Verification of information in application made under regulation 22

23.—(1) Upon receipt of an application under regulation 22, the Food Standards Agency must—

(a) acknowledge receipt of the application;

(b) verify whether the application contains the information specified in Schedule 4 (as read with regulation 22(3)).

(2) If, notwithstanding any further information provided pursuant to regulation 24, the application does not contain the information specified in Schedule 4, the Food Standards Agency must advise the applicant that the application is invalid.

(3) If the application contains the information specified in Schedule 4, the Food Standards Agency must determine the requirements of the assessment of the safety of the precision bred organism for use in food and feed to be carried out under regulation 26, which may include a risk assessment.

Request for further information

24.—(1) The Food Standards Agency may request that the applicant provides further information, including evidence, in support of their application, if required, as part of the verification under regulation 20(7)(b) or regulation 23(1)(b).

(2) Where the Food Standards Agency has requested further information under paragraph (1), the applicant must provide that information within the time period specified by the Food Standards Agency in the request.

(3) If the further information requested under paragraph (2) is not provided within the time period specified by the Food Standards Agency, the application is to be treated as withdrawn and the Food Standards Agency must advise the applicant accordingly.

Publication of verified applications

25.  The Food Standards Agency must publish summaries of applications which have been verified under regulation 20(7)(b) or regulation 23(1)(b)(7).

Assessment by the Food Standards Agency

26.—(1) Where the Food Standards Agency determines under regulation 23(3) that the information provided in accordance with regulation 22(2) is sufficient to demonstrate the safety of the precision bred organism for use in food and feed without further assessment, the Food Standards Agency must report their conclusions on the application to the Secretary of State together with an assessment of any other legitimate factors the Food Standards Agency considers relevant to the issuing of a food and feed marketing authorisation.

(2) The Food Standards Agency may take into account any further information provided under regulation 24 or any other information available to the Food Standards Agency through other means when preparing a report under paragraph (1).

(3) If paragraph (1) does not apply, the Food Standards Agency must carry out an assessment of the safety of the precision bred organism for use in food and feed, having particular regard to the matters referred to in regulation 22(1)(b).

(4) The Food Standards Agency may request that the applicant provides further information, including evidence, as part of the assessment under paragraph (3).

(5) Where the Food Standards Agency has requested further information under paragraph (4), the applicant must provide that information within the time period specified by the Food Standards Agency in the request.

(6) If the further information requested under paragraph (5) is not supplied within the time period specified by the Food Standards Agency the application is to be treated as withdrawn and the Food Standards Agency must advise the applicant accordingly.

Advice or information from the Food Standards Advisory Committee etc.

27.—(1) The Food Standards Agency may consult or request advice or information in relation to the application from the Food Standards Advisory Committee or such other persons with the relevant expertise as necessary to enable the Food Standards Agency to conduct an assessment.

(2) The Food Standards Agency must forward a summary of the application and any other relevant information to any committee or other person that it consults or requests advice or information from under paragraph (1).

(3) Any advice or information provided under paragraph (1) must be provided without undue delay.

(4) The Food Standards Agency must publish any advice or information provided under paragraph (1) unless that advice or information is treated as commercially confidential by the applicant and the Food Standards Agency under regulation 34(8).

(5) Any obligations imposed on any committee or other persons under this regulation are not Part 3 obligations(9).

Requirement to report on safety assessment etc. to the Secretary of State

28.  Where regulation 26(3) applies, the Food Standards Agency must provide the Secretary of State with a report advising the Secretary of State on the following matters—

(a) the outcome of the assessment of the safety of the precision bred organism for use in food and feed conducted by the Food Standards Agency including any recommendations to the Secretary of State arising from it;

(b) whether the criteria in sub-paragraphs (a) to (d) of regulation 30(3) are met;

(c) an assessment of any other legitimate factors which may be relevant to the application under consideration;

(d) whether the food and feed marketing authorisation should be subject to—

(i) any conditions;

(ii) any limitations,

including any recommendations to the Secretary of State regarding those conditions or limitations;

(e) any other relevant matters.

Withdrawal of application for a food and feed marketing authorisation

29.  An applicant may withdraw an application at any time by giving notice to the Food Standards Agency.

Determination on authorisation by the Secretary of State

30.—(1) Upon receipt of a report from the Food Standards Agency under regulation 21 or 28 the Secretary of State must decide whether to issue a food and feed marketing authorisation.

(2) If the Secretary of State decides to issue a food and feed marketing authorisation, the Secretary of State must decide—

(a) any conditions to which the authorisation must be subject;

(b) any limitations to which the authorisation must be subject.

(3) The Secretary of State may issue a food and feed marketing authorisation if it appears to the Secretary of State that—

(a) any food or feed produced from the organism to which the food and feed marketing authorisation would apply would not have adverse effects on animal or human health;

(b) the way in which any such food or feed would be placed on the market would not mislead consumers;

(c) the production of any such food or feed in place of other food or feed that it might reasonably be expected to replace would not have adverse effects on the environment;

(d) consuming any such food or feed in place of other food or feed that it might reasonably be expected to replace would not be nutritionally disadvantageous to humans or animals.

(4) When considering whether the requirements in paragraph (3) are met, the Secretary of State must—

(a) have regard to any report which has been provided by the Food Standards Agency under regulation 21 or 28;

(b) not apply any test in connection with these requirements which would not otherwise be applicable in relation to any food or feed produced from organisms which are not produced from the application of modern biotechnology.

(5) The Secretary of State must not issue a food and feed marketing authorisation if—

(a) the Secretary of State concludes from the assessment of the safety of the precision bred organism or having considered any other legitimate factors that a food and feed marketing authorisation cannot be issued;

(b) an application has been made under regulation 20 and the Secretary of State cannot reasonably conclude that the requirements of regulation 20(1) have been met.

(6) The Secretary of State must advise the Food Standards Agency of the decisions under paragraphs (1) and (2) (where applicable) as soon as reasonably practicable following receipt of the report from the Food Standards Agency.

(7) If the Secretary of State decides not to issue a food and feed marketing authorisation, the Secretary of State must give reasons for the decision to the Food Standards Agency.

Communication of the Secretary of State’s decision to the applicant

31.—(1) The Food Standards Agency must notify the applicant of the Secretary of State’s decisions under regulation 30(1) and (2) (where applicable) as soon as reasonably practicable following receipt of the decisions.

(2) The notification must include the following information—

(a) whether a food and feed marketing authorisation has been issued by the Secretary of State;

(b) the date the decision was made;

(c) if a food and feed marketing authorisation has been issued—

(i) any conditions to which it is subject,

(ii) any limitations to which it is subject;

(d) if a food and feed marketing authorisation has not been issued, the reasons for the decision.

Duties on authorisation-holders and other persons placing authorised food and feed on the market

32.—(1) The authorisation-holder and other persons placing on the market food or feed produced from a precision bred organism in respect of which a food and feed marketing authorisation is in force must comply with any conditions or limitations to which the food and feed marketing authorisation is subject.

(2) In this regulation, and regulation 33, a food and feed marketing authorisation is “in force” if it has been issued and not revoked.

(3) An authorisation-holder or other persons placing on the market, or proposing to place on the market, food or feed produced from a precision bred organism in respect of which a food and feed marketing authorisation is in force must advise the Food Standards Agency immediately if they—

(a) become aware of any change in circumstances that may affect the safe use of the precision bred organism in food or feed;

(b) are proposing to apply a production process to the precision bred organism or the food produced from it which would, but for the application of Article 2(2)(aa) of Regulation (EC) 2015/2283 of the European Parliament and of the Council on novel foods, etc.(10), result in a new food being produced that falls within the definition set out in Article 3(2)(a) of that Regulation.

(4) Where an authorisation-holder or other person placing on the market, or proposing to place on the market, food or feed produced from a precision bred organism in respect of which a food and feed marketing authorisation is in force is uncertain whether paragraph (3) applies they must consult the Food Standards Agency for advice.

Revocation or variation of a food and feed marketing authorisation

33.—(1) The Secretary of State may revoke or vary a food and feed marketing authorisation in the following circumstances—

(a) if the Food Standards Agency or the Secretary of State becomes aware of—

(i) any new scientific or technical information which might influence the assessment of the safety of the precision bred organism for use in food and feed;

(ii) any other information which might affect the assessment of the safety of the precision bred organism for use in food and feed;

(iii) any information suggesting that a precision bred organism in respect of which a food and feed marketing authorisation is in force, or food produced from that precision bred organism, has been subject to a subsequent production process which would, but for the application of Article 2(2)(aa) of Regulation (EC) 2015/2283 of the European Parliament and of the Council on novel foods, etc., result in a new food being produced that falls within the definition set out in Article 3(2)(a) of that Regulation;

(b) if an authorisation-holder notifies the Food Standards Agency that—

(i) the authorisation-holder is no longer satisfied that the conditions or limitations to which the food and feed marketing authorisation is subject are sufficient to ensure the safety of the food or feed produced from the precision bred organism in respect of which the food and feed marketing authorisation is in force;

(ii) the authorisation-holder is satisfied that any of the conditions or limitations to which the food and feed marketing authorisation is subject is no longer required.

(2) If the authorisation-holder is proposing a variation to the food and feed marketing authorisation, the authorisation-holder must make an application to the Food Standards Agency setting out the proposed variation and the reasons for the request.

(3) If a variation to the food and feed marketing authorisation is proposed because of an administrative or other change that does not affect the safe use of the precision bred organism in food and feed, the authorisation-holder must apply to the Food Standards Agency setting out the variation proposed and the reasons for it so that the food and feed register can be updated in accordance with regulation 35(6).

(4) The authorisation-holder must be given the opportunity to respond to the information referred to in paragraph (1)(a) within a reasonable time period unless the urgency of the matter does not allow it.

(5) Where the Secretary of State becomes aware of information under paragraph (1), the Secretary of State must request a report from the Food Standards Agency assessing whether the food and feed marketing authorisation continues to be sufficient to ensure the safety of the precision bred organism for use in food and feed.

(6) Where the Food Standards Agency becomes aware of information under paragraph (1) or where the Secretary of State requests a report under paragraph (5), the Food Standards Agency must prepare a report for the Secretary of State assessing whether the food and feed marketing authorisation continues to be sufficient to ensure the safety of the precision bred organism for use in food and feed.

(7) If the Food Standards Agency concludes that variations to the food and feed marketing authorisation would be appropriate, the Food Standards Agency must include a recommendation in the report that the food and feed marketing authorisation should be varied.

(8) In preparing its report, the Food Standards Agency may—

(a) request further information or evidence from the authorisation-holder or any person placing, or proposing to place on the market, food or feed produced from the precision bred organism in respect of which the food and feed marketing authorisation is in force;

(b) consult or request advice or information from the Food Standards Advisory Committee or such other persons with the relevant expertise as necessary to enable the Food Standards Agency to prepare the report under paragraph (6).

(9) The authorisation-holder must provide any information requested by the Food Standards Agency under paragraph (8)(a) within the time period specified by the Food Standards Agency in the request.

(10) If the authorisation-holder fails to provide the information within the time period specified by the Food Standards Agency, the Food Standards Agency must prepare its report based on information that is available to the Food Standards Agency.

(11) Any advice or information provided under paragraph (8)(b) must be provided without undue delay.

(12) The Food Standards Agency must publish any advice or information provided under paragraph (8)(b) unless that advice or information is treated as commercially confidential by the applicant and the Food Standards Agency under regulation 34.

(13) Any obligations imposed on any committee or other persons under paragraph (8)(b) are not Part 3 obligations.

(14) Having considered the report provided by the Food Standards Agency under paragraph (6), the Secretary of State must decide what, if any, measures are appropriate to take in respect of the food and feed marketing authorisation, which may include the variation or revocation of the food and feed marketing authorisation or cancelling, adding to or varying any limitation or condition to which the food and feed marketing authorisation is subject.

(15) The measures decided under paragraph (14) may include transitional arrangements.

(16) The Food Standards Agency must report the Secretary of State’s decision under paragraph (14) to the authorisation-holder as soon as reasonably practicable.

Confidentiality

34.—(1) Where an applicant has included a statement in the application for a food and feed marketing authorisation in accordance with paragraph 1(6) of Schedule 4, indicating that certain information should be treated as commercially confidential, the Food Standards Agency must decide which of the information identified it proposes to treat as commercially confidential and notify the applicant of its decision.

(2) After being informed of the Food Standards Agency’s decision, the applicant may withdraw their application before the end of the period of 21 days beginning with the day on which notice of the decision was sent by the Food Standards Agency, during which period the confidentiality of the information provided must be observed by the Food Standards Agency.

(3) The Food Standards Agency may decide that information provided under regulations 32 and 33 is commercially confidential except where paragraph (5) applies.

(4) Information may be treated as commercially confidential if disclosure of such information would, or would be likely to, prejudice the commercial interests of any person or is a trade secret.

(5) The following information must not be considered commercially confidential—

(a) the information set out in regulation 35 (the food and feed marketing authorisations register);

(b) information relevant to the effects of the precision bred organism for use in food and feed on human or animal health.

(6) The Food Standards Agency must take the necessary measures to ensure appropriate confidentiality of the information that the Food Standards Agency has decided is to be treated as commercially confidential except for information which must be made public if circumstances so require in order to protect human or animal health.

(7) If an applicant withdraws or has withdrawn an application, the Food Standards Agency must respect the confidentiality of any commercial information—

(a) which the applicant has indicated should be treated as confidential;

(b) in respect of which a claim for confidentiality is disputed.

(8) Paragraphs (1) to (7) do not prevent the exchange of information treated as commercially confidential between the Food Standards Agency and the Secretary of State.

(1)

“Food and feed marketing authorisation” is defined in section 30(1) of the Act.

(2)

1999 c. 28 to which there are amendments not relevant to these Regulations.

(3)

Section 30(3) of the Act makes provision about the meaning of food or feed being placed on the market.

(4)

“Marketable precision bred organism” is defined in section 5(2) of the Act.

(5)

“Qualifying progeny” is defined in section 24 of the Act.

(6)

“In force” in respect of a precision bred confirmation is defined in section 5(5) of the Act.

(7)

See also regulation 35.

(8)

See also regulation 35.

(9)

“Part 3 obligation” is defined in section 29(1) of the Act (see also section 29(3)(b) of the Act).

(10)

EUR 2015/2283 amended by S.I. 2019/702; there are other amendments but none is relevant. Schedule 5 to this instrument inserts article 2(2)(aa).