Regulation 33 Revocation or variation of a food and feed marketing authorisation
The Secretary of State may revoke or vary a food and feed marketing authorisation in the following circumstances—
if the Food Standards Agency or the Secretary of State becomes aware of—
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;
any other information which might affect the assessment of the safety of the precision bred organism for use in food and feed;
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;
if an authorisation-holder notifies the Food Standards Agency that—
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;
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.
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.
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).
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.
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.
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.
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.
In preparing its report, the Food Standards Agency may—
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;
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).
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.
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.
Any advice or information provided under paragraph (8)(b) must be provided without undue delay.
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.
Any obligations imposed on any committee or other persons under paragraph (8)(b) are not Part 3 obligations.
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.
The measures decided under paragraph (14) may include transitional arrangements.
The Food Standards Agency must report the Secretary of State’s decision under paragraph (14) to the authorisation-holder as soon as reasonably practicable.