Draft  Regulations  laid befor e Parliament  under  section  43(4)  of the Genetic  Technology  (Precision 
Breeding)  Act 2023  (c. 6), for approval by resolution  of each  House  of Parliament. 
DRAFT  STATUT OR Y INSTRUMENTS 
2024  No. 
ENVIRONMENT AL PROTECTION , ENGLAND 
FOOD , ENGLAND 
The Genetic  Technology  (Precision  Breeding)  (England) 
Regulations  2024 
- - - - Made 
- - Coming  into force 
The Secretary  of State  makes  these  Regulations  in exercise  of the powers  conferred  by sections 
4(3) and (4), 6(2),  9(1),  (2) and (4), 16(1),  (2) and (4), 17(1)  and (3), 18(6),  20(1),  (2) and (3), 
21(3),  23(1),  26(1),  (2), (3), (4), (7) and (8), 27(1)  and (2), 28(1)  and (3), 29(4),  31(3),  32(1)  and 
(2), 33(2),  34(2),  35(3)  and (4), 36(1)  and (3), 37, 38(1),  (4), (5) and (7), 40(1),  42(1)  and (2), 
43(3)  and (6) of the Genetic  Technology  (Precision  Breeding)  Act 2023 (a). 
The Secretary  of State  has carried  out the consultation  required  by Article  9 of Regulation  (EC) 
No 178/2002  of the European  Parliament  and of the Counsel  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 (b) 
In accordance  with section  43(4)  of the Act, a draft  of this instrument  has been  laid before,  and 
approved  by a resolution  of, each House  of Parliament. 
PART 1 
Introduction 
Citation,  commencement,  extent  and application 
1. —(1) These  Regulations  may be cited  as the Genetic  Technology  (Precision  Breeding) 
(England)  Regulations  2024  and come  into force  [ ]. 
(a) 2023  c.6. 
(b) OJ No. L31, 1.2.2002,  p.1, last amended  by Regulation  (EU)  2019/1381  of the European  Parliament  and of the Council 
of 20 June 2019  (OJ No. L231,  6.9.2019,  p. 1-28). (2) Subject  to paragraph  (3), this Part and regulation  45 of, and Schedule  5 to, these  Regulations 
extend  to the United  Kingdom. 
(3) An amendment  to a provision  has the same  extent  as the provision  being  amended. 
(4) Otherwise,  these  Regulations  extend  to England  and Wales but apply  in England  only. 
Interpr etation 
2. In these  Regulations  — 
“the Act” means  the Genetic  Technology  (Precision  Breeding  Act) 2023 (a); 
“the advisory  committee”  has the meaning  in section  22(1)  of the Act; 
“the Food  and Feed  Register”  means  the register  containing  particulars  relating  to food 
and feed marketing  authorisations  established  and maintained  in accordance  with section 
27(1)  of the Act and regulation  27 of these  Regulations; 
“precision  bred organism”  means  a precision  bred plant (b); 
“the Precision  Breeding  Register”  means  the register  of precision  bred organisms  established 
and maintained  in accordance  with section  18 of the Act and regulations  10 and 11 of 
these  Regulations; 
PART 2 
Release  of Precision  Bred  Organisms 
Notification  requir ement  for release  of precision  bred organisms  in England 
3. —(1) This regulation  applies  in relation  to the release (c) of a precision  bred organism  in 
England  by a person  in accordance  with section  3(1) of the Act. 
(2) The release  notice  must  specify  the following  persons  in relation  to the release— 
(a) the person  who is proposing  to release  the precision  bred organism  from  under  their 
control; 
(b) if the person  in paragraph  (a) is a legal  person,  a natural  person  who is an employee  or 
agent  of the legal  person  who may be contacted  in relation  to the release  notice; 
(c) a general  description  of other  persons  who may assist  in the release. 
(3) A person  to whom  paragraph  (2)(a)  applies  must— 
(a) give the release  notice  to the Secretary  of State  at least 20 days before  the day on which 
the organism  is to be released  beginning  with the day the release  notice  is received  by 
the Secretary  of State (d); 
(b) ensure  the release  notice  contains  the information  required  in Schedule  1 to these 
Regulations. 
(4) The release  notice  may contain  any other  information  that the person  giving  the notice 
considers  relevant. 
(5) More  than one precision  bred organism  may be notified  in a single  release  notice  provided 
that— 
(a) 2023  c. 6. 
(b) “plant”  is defined  in section  2(1) of the Act. 
(c) “release”  has the meaning  in section  3(3) of the Act. 
(d) See regulation  43 of these  Regulations. 
2 (a) the precision  bred organisms  are from  the same  species;  and 
(b) the organisms  contain  only the changes,  or combinations  of those  changes,  described  in 
the release  notice  in accordance  with paragraph  4 of Schedule  1, and paragraph  2 of 
Schedule  3, to these  Regulations. 
Transitional  provisions  for release 
4. —(1) When  the circumstances  in paragraph  (2) apply , the procedure  in paragraph  (3) must 
be followed. 
(2) The circumstances  referred  to in paragraph  (1) are— 
(a) a notifier  has given  the Secretary  of State  a notification  to release  Qualifying  Higher 
Plants  pursuant  to the Genetically  Modified  Organisms  (Deliberate 
Release)(Amendment)(England)  Regulations  2022  (a) before  the coming  into force  of 
these  Regulations;  and 
(b) the Qualifying  Higher  Plants  covered  by the notification  in sub-paragraph  (a) include 
plants  which— 
(i) will be under going  field trials  after the coming  into force  of these  Regulations,  and 
(ii) have  not been  released  before  the coming  into force  of these  Regulations. 
(3) A notifier  must  give to the Secretary  of State  a release  notice  covering  those  Qualifying 
Higher  Plants  notified  under  the regulations  referred  to in paragraph  (2)(a)  in accordance  with 
regulation  3 of these  Regulations  within  3 months  beginning  with the date these  Regulations 
come  into force. 
PART 3 
Marketing  of Precision  Bred  Organisms 
Application  for precision  bred confirmation 
5. —(1) This regulation  applies  in relation  to the giving  of a marketing  notice  under  section 
6(1) of the Act. 
(2) A marketing  notice  under  paragraph  (1) must  contain  the information  required  in Schedule 
2 to these  Regulations. 
(3) The marketing  notice  may contain  any other  information  that the notifier  considers  relevant. 
(4) A marketing  notice  may include  more  than one precision  bred organism  provided  the 
precision  bred organisms  comply  with paragraph  7 of Schedule  2 to these  Regulations. 
(5) The notifier  may withdraw  a marketing  notice  at any time before  the Secretary  of State 
makes  a decision  under  section  8(1) of the Act by giving  a request  to the Secretary  of State. 
The advisory  committee  - reporting  period  etc 
6. —(1) Subject  to paragraph  (2), where  the Secretary  of State  has referred  a marketing  notice 
to the advisory  committee  under  section  6(3) of the Act and the advisory  committee  subsequently 
requests  further  information  from  the notifier  under  section  7(3) of the Act, the reporting  period 
does not run from  the date of the information  notice  requesting  the further  information  until 
receipt  by the advisory  committee  of the further  information  requested. 
(a) S.I. 2022/347. 
3 (2) If the information  requested  in the information  notice  is not provided  within  60 days of the 
date of the information  notice,  the marketing  notice  may be treated  as withdrawn. 
Revocation  of precision  bred confirmation 
7. —(1) The Secretary  of State  may revoke  a precision  bred confirmation  if the Secretary  of 
State  is no longer  satisfied  that the organism  is precision  bred in any of the following 
circumstances— 
(a) the notifier  or other  person  named  in the marketing  notice  notifies  the Secretary  of State 
directly  or indirectly  that the organism  is not precision  bred; 
(b) the Secretary  of State  reasonably  suspects  that a notifier  or other  person  named  in a 
marketing  notice  has provided  false  or misleading  information  in the marketing  notice; 
(c) the Secretary  of State  is provided  with new genetic  information  about  an organism  with 
precision  bred confirmation. 
(2) Where  reasonable  evidence  is made  available  to the Secretary  of State  under  paragraph  (1) 
by a person  other  than the notifier , the Secretary  of State  must  give notice  to the notifier  that 
information  has been  provided  to the Secretary  of State  under  paragraph  (1). 
(3) A notice  under  paragraph  (2) must  include— 
(a) the information  provided  under  paragraph  (1) that indicates  why the organism  may not 
be precision  bred; 
(b) the date by which  the notifier  must  respond  to the notice. 
(4) Where  the Secretary  of State  proposes  to revoke  a precision  bred confirmation,  the Secretary 
of State  must— 
(a) publish  notice  of the proposal  to revoke  the precision  bred confirmation  in any way that 
the Secretary  of State  considers  appropriate  to bring  it to the attention  of those  affected 
by it; 
(b) invite  those  affected  by the proposal  to make  representations  to the Secretary  of State 
about  it. 
(5) The Secretary  of State  may request  a report  from  the advisory  committee  considering  whether 
the precision  bred organism  should  be revoked  where  the Secretary  of State  has— 
(a) provided  to the advisory  committee  the documentation  available  under  paragraph  (1) 
and any response  from  the notifier  provided  following  a notice  under  paragraph  (2); 
(b) agreed  the time period  within  which  the advisory  committee  will provide  its report. 
(6) As soon  as practicable  after completion  of the steps  in paragraphs  (2), (4) and (5), the 
Secretary  of State  must— 
(a) if satisfied  that the organism  is not precision  bred— 
(i) issue  a revocation  notice,  and 
(ii) give notice  of it to the notifier; 
(b) If satisfied  that the organism  is precision  bred,  give notice  to the notifier  of that fact. 
(7) A revocation  notice  under  paragraph  (6)(a)(i)  must  include  the following— 
(a) notice  that the precision  bred confirmation  is being  revoked; 
(b) the date of the revocation; 
(c) the reasons  for the revocation; 
(d) circumstances  in which  the revocation  notice  may be reviewed  and appealed; 
(e) the procedure  for the review  or appeal; 
4 (f) the steps  to be taken  by the notifier  following  receipt  of the revocation  notice. 
(8) Following  the revocation  of a precision  bred organism,  the Secretary  of State  may— 
(a) direct  that a precision  bred organism,  or food or feed produced  from  a precision  bred 
organism (a), be recalled  or withdrawn  from  the market; 
(b) require  the publication  of details  of the revocation  in any way that the Secretary  of State 
considers  appropriate  to bring  it to the attention  of those  that may be affected  by it; 
(c) direct  appropriate  steps  to identify  purchasers  or users  of the precision  bred organism 
in order  to notify  them  of the revocation  and the consequences  for the regulation  of the 
organism. 
(9) The Secretary  of State  must  update  the Precision  Breeding  Register  with details  of the 
revocation  in accordance  with regulation  11 of these  Regulations. 
(10) Revocation  of a precision  bred confirmation  under  this regulation  has the effect that any 
food and feed marketing  authorisation  issued  under  regulation  23 of these  Regulations  in reliance 
on the organism  being  a marketable  precision  bred organism  for the purposes  of any requirement 
imposed  by virtue  of section  26(3)(a)  of the Act must  also be treated  as revoked  and the Secretary 
of State  must  accordingly— 
(a) notify  the Food  Standards  Agency  that the precision  bred confirmation  has been revoked; 
and 
(b) supply  a copy  of the revocation  notice  issued  under  paragraph  (6)(a)(i)  to the Food 
Standards  Agency  to enable  the Food  and Feed  Register  to be updated  with notice  of 
the revocation. 
Review  of a precision  bred confirmation  or revocation  decision 
8. —(1) A notifier  who receives  a notice  under— 
(a) section  8(1)(b)  of the Act (decision  not to issue  a precision  bred confirmation);  or 
(b) regulation  7(6)(a)  of these  Regulations  (a decision  to revoke  a precision  bred 
confirmation) 
may require  the Secretary  of State  to review  the decision  to issue  the notice. 
(2) A person  with an interest  in a notice  issued  under  regulation  7(6)(a)  may require  the Secretary 
of State  to review  the decision  to issue  the notice. 
(3) A request  for a review  under  paragraphs  (1) or (2) must  be made  within  28 days of the 
date of receipt  of the relevant  notice. 
(4) The grounds  for a review  are— 
(a) that the decision  was based  on an error  of fact; 
(b) that the decision  was wrong  in law; 
(c) that the decision  was unreasonable  for any reason. 
(5) As part of the review , the Secretary  of State  may give due regard  to any additional 
information  or evidence  provided  to it. 
(6) Upon  reviewing  a decision  under  this regulation,  the Secretary  of State  must— 
(a) decide  whether  to confirm,  vary or withdraw  the notice; 
(b) give notice  to the notifier , and any person  with an interest  who has requested  a review 
under  paragraph  (2), setting  out— 
(i) the Secretary  of State’ s decision, 
(a) food or feed produced  “from”  a precision  bred organism  has the meaning  in section  30(2)  of the Act. 
5 (ii) the reasons  for that decision; 
(c) inform  the notifier , and any person  with an interest  who has requested  a review  under 
paragraph  (2), of the right  to appeal  to the First-tier  Tribunal. 
(7) The Secretary  of State  may suspend  the operation  of a revocation  notice  to which  the review 
relates  pending  the outcome  of the review . 
Appeal  to the First-tier  Tribunal 
9. —(1) A notifier , or person  with an interest  in a notice,  who requested  a review  under 
regulation  8(1) and is not satisfied  with the outcome  of the review  under  that regulation  may 
appeal  to the First-tier  Tribunal. 
(2) An appeal  to the First-tier  Tribunal  under  paragraph  (1) must  be made  within  28 days of 
the date of notification  of the review  decision  under  regulation  8. 
(3) The grounds  for appeal  are— 
(a) that the decision  was based  on an error  of fact; 
(b) that the decision  was wrong  in law; 
(c) that the decision  was unreasonable  for any reason. 
(4) The First-tier  Tribunal  may give due regard  to any additional  information  or evidence 
provided  to it. 
(5) Upon  consideration  of any appeal  under  this regulation,  the First-tier  Tribunal,  may— 
(a) withdraw  the notice; 
(b) confirm  the notice; 
(c) vary the notice; 
(d) take such steps  as the Secretary  of State  could  take in relation  to the notice; 
(e) remit  the decision  whether  to confirm  the notice,  or any matter  relating  to that decision, 
to the Secretary  of State. 
(6) The First-tier  Tribunal  may suspend  the operation  of a notice  to which  the review  relates 
pending  the outcome  of the appeal. 
PART 4 
The Precision  Breeding  Register 
Information  to be included  in the Precision  Breeding  Register 
10. —(1) The Precision  Breeding  Register  must  contain  the particulars  set out in paragraphs 
(3) to (5). 
(2) Paragraphs  (3) to (5) are subject  to section  18(2)  of the Act (commercially  confidential 
information). 
(3) The Secretary  of State  must  add the following  information  about  a release  notice  to the 
Precision  Breeding  Register— 
(a) the name  and address  of the person  proposing  to release  the precision  bred organism 
from  under  their control; 
(b) a description  of other  persons  who may assist  in the release  of the precision  bred 
organism; 
6 (c) a general  description  of the precision  bred organism  covered  by the release  notice  in 
accordance  with Schedule  3 to these  Regulations; 
(d) the confirmations  provided  in accordance  with paragraph  5 of Schedule  1 to these 
Regulations. 
(4) The Secretary  of State  must  add the following  information  about  a marketing  notice  to the 
Precision  Breeding  Register— 
(a) the name  and address  of the person  with overall  responsibility  for marketing  the precision 
bred organism; 
(b) a general  description  of the precision  bred organism  covered  by the marketing  notice 
in accordance  with Schedule  3 to these  Regulations; 
(c) a description  of the intended  use of the precision  bred organism  covered  by the marketing 
notice; 
(d) a description  of the changes  made  to the precision  bred organism  covered  by the 
marketing  notice; 
(e) a description  of how the genetic  changes  were  introduced  into the precision  bred 
organism; 
(f) A description  of the analysis  and procedures  that have  been  undertaken  to— 
(i) minimise  the potential  for unintended  genetic  changes, 
(ii) identify  any unintended  genetic  changes  likely  to have  resulted  from  the use of 
modern  biotechnology (a); 
(g) If the marketing  notice  covers  more  than one precision  bred organism,  a summary  of 
those  precision  bred organisms; 
(h) a summary  of any advice  the Secretary  of State  has received  from  the advisory  committee 
as to whether  the organism  covered  by the marketing  notice  is precision  bred and either— 
(i) whether  the advisory  committee  considers  the organism  to be precision  bred,  or 
(ii) a summary  of the scientific  reasoning  why the advisory  committee  has advised  that 
the organism  is not precision  bred; 
(i) any information  provided  to the advisory  committee  in accordance  with an information 
notice  given  by the committee; 
(j) information  relating  to a withdrawal  of a marketing  notice. 
(5) The Secretary  of State  must  add the following  information  about  a precision  bred 
confirmation— 
(a) a copy  of the precision  bred confirmation  and a reference  to the marketing  notice  in 
respect  of which  it was issued; 
(b) the fact that a precision  bred confirmation  has been  revoked  and the contents  of the 
notice  by which  the confirmation  was revoked; 
(c) any advice  received  from  the advisory  committee  as to whether  a precision  bred 
confirmation  should  be revoked; 
(d) a summary  of any enforcement  notices  issued  relating  to the precision  bred confirmation. 
Keeping  of the precision  breeding  register 
11. —(1) The information  prescribed  in regulation  10(3)  must  be added  to the Precision  Breeding 
Register  within  20 days of the date of receipt  of the release  notice  by the Secretary  of State. 
(a) “Modern  biotechnology”  is defined  in section  1(3) of the Act. 
7 (2) The information  prescribed  in regulation  10(4)(a)  to (i) and 10(5)(a)  must  be added  to the 
Precision  Breeding  Register  as soon  as reasonably  practicable  after the Secretary  of State  has 
made  a decision  under  section  8(1) of the Act. 
(3) The information  prescribed  in regulation  10(4)(j)  must  be added  to the Precision  Breeding 
Register  as soon  as reasonably  practicable  after the marketing  notice  has been  withdrawn. 
(4) The information  prescribed  in regulation  10(5)(b)  and (c) must  be added  to the Precision 
Breeding  Register  as soon  as reasonably  practicable  after the revocation  of the precision  bred 
confirmation  by the Secretary  of State  under  regulation  7(6). 
(5) The information  prescribed  in regulation  10(5)(d)  must  be added  to the Precision  Breeding 
Register  as soon  as reasonably  practicable  after the enforcement  notice  has been  served  on the 
notifier . 
PART 5 
Risk Assessment 
Risk  assessment  for precision  bred organisms  in contained  use 
12. —(1) [Placeholder  - This regulation  will provide  for restrictions  on importation  and 
acquisition  of precision  bred plants  in contained  use conditions  by maintaining  the existing 
requirements  placed  on genetically  modified  organisms  and precision  bred plants  in those 
conditions.] 
PART 6 
Monitoring  and Inspection  of Release  and Marketing 
Inspectors 
13. —(1) In this Part “inspector”  means  an inspector  appointed  by the Secretary  of State  under 
section  19 of the Act. 
(2) An inspector  under  paragraph  (1) has the following  functions— 
(a) monitoring  compliance  with Part 2 obligations; 
(b) investigating  suspected  failures  to comply  with Part 2 obligations. 
Meaning  of “Part  2 obligations” 
14. For the purposes  of the Act and these  Regulations (a), references  to a failure  to comply  with 
a Part 2 obligation  include  references  to providing  or recording  information,  or making  a statement 
that is false  or misleading— 
(a) in purported  compliance  with a Part 2 obligation; 
(b) in connection  with any application  or review , or any proposal  to revoke  a precision  bred 
organism  under  Part 2 of the Act. 
Inspection 
15. —(1) For the purposes  of carrying  out their functions,  inspectors  may— 
(a) See section  21 of the Act as regards  the meaning  of Part 2 obligation. 
8 (a) on producing,  if so required,  some  duly authenticated  document  confirming  the inspector ’s 
authority; 
(b) at any reasonable  hour; 
(c) enter  any land or premises,  other  than a private  dwelling. 
(2) Inspectors  must  inform  the owner  or occupier  or person  who has control  of the land or 
premises  of the purpose  of the proposed  inspection  and, where  possible,  agree  a suitable  date and 
time for that inspection. 
(3) Where  it is not possible  to agree  a suitable  date and time,  the inspector  must  notify  the 
owner  or occupier  or person  who has control  of the land or premises  of the purpose  of the 
inspection  and the date and time at least 48 hours  in advance  of that inspection. 
Powers  of entry 
16. —(1) An inspector  may, at any reasonable  hour, enter  any land or premises,  other  than a 
private  dwelling,  without  notice,  if— 
(a) there  is a reasonable  suspicion  of— 
(i) a failure  to comply  with a Part 2 obligation, 
(ii) an offence  having  been committed  under  any other  legislation  insofar  as it is relevant 
to a Part 2 obligation; 
(b) the inspector  produces,  if so required,  a duly authenticated  document  confirming  the 
inspector ’s authority;  and 
(c) one of the conditions  in paragraph  (4) is met. 
(2) An inspector  may, at any reasonable  hour, enter  any private  dwelling  without  notice  if a 
warrant  has been  obtained  in accordance  with paragraph  (3). 
(3) A justice  of the peace  may, by signed  warrant,  permit  an inspector  to enter  any private 
dwelling,  if the justice  on sworn  information  in writing  is satisfied  that— 
(a) there  is a reasonable  basis  for the suspicion  under  paragraph  (1)(a); 
(b) one or more  of the conditions  in paragraph  (4) is met; and 
(c) if only the condition  in paragraph  (4)(a)  is met— 
(i) notice  of intention  to apply  for a warrant  has been  served  on the owner  or occupier 
or other  person  with control  of the property , or 
(ii) such notice  has not been  served  because  serving  such a notice  would  interfere  with 
the purpose  or effectiveness  of the entry . 
(4) The conditions  are that— 
(a) entry  to the land or premises  has been  refused  or the Secretary  of State  has reasonable 
grounds  to suspect  that entry  is likely  to be refused; 
(b) entry  is required  urgently; 
(c) the land or premises  are unoccupied  or the occupier  is temporarily  absent. 
(5) A warrant  signed  in accordance  with paragraph  (3) is valid  for one month  from  the date of 
the signature. 
(6) An inspector  who enters  any land or premises  which  are unoccupied  or from  which  the 
occupier  is temporarily  absent  must  leave  them  as effectively  secured  as they were  before  entry . 
9 Powers  of inspection 
17. —(1) An inspector  who carries  out an inspection  of premises  in accordance  with regulations 
15 or 16, may— 
(a) inspect  and search  premises; 
(b) take copies  of documents; 
(c) take photographs  and samples; 
(d) require  the provision  of information. 
(2) Information  obtained  under  paragraph  (1)(d)  must  not be used or disclosed  otherwise  than 
for the purposes  of Part 2 of the Act or Part 6 of the Environmental  Protection  Act 1990 (a). 
(3) Inspectors  may be accompanied  by such other  persons  as the inspector  considers  necessary 
in carrying  out their functions  under  this Part. 
(4) The owner  or occupier  of the premises  or such other  person  with control  of the premises, 
or the employee  or agent  of that person  must  give the inspector  such assistance  as the authorised 
person  may reasonably  request. 
PART 7 
Food  and Feed  produced  from  Precision  Bred  Organisms 
Interpr etation  in this Part 
18. —(1) In this Part— 
“applicant” means  a person  who applies  for a food and feed marketing  authorisation (b); 
“authorisation-holder”  means  a person  who has been  granted  a food and feed marketing 
authorisation  under  this Part; 
“Food  Standards  Advisory  Committee”  means  the Advisory  Committee  on Novel  Foods 
and Processes  or any other  advisory  committee  appointed  under  section  5(3) of the Food 
Standards  Act 1999 (c); 
“a marketing  authorisation”  means  a food and feed marketing  authorisation; 
“representative” means  the representative  of the applicant  established  in Great  Britain  (if 
the applicant  is not established  in Great  Britain).  A reference  to an applicant  includes  their 
representative. 
Marketing  of food  and feed produced  from precision  bred organisms 
19. —(1) No person  may place  on the market (d) in England  food or feed produced  from 
precision  bred organisms  unless— 
(a) a marketing  authorisation  in respect  of the food or feed has been  issued  by the Secretary 
of State  in accordance  with this Part; 
(b) any conditions  or limitations  attaching  to the marketing  authorisation  are satisfied;  and 
(c) the marketing  authorisation  has not been  revoked. 
(2) A precision  bred organism  under  this Part must  be— 
(a) 1990  c. 43. 
(b) “Food  and feed marketing  authorisation”  is defined  in section  30(1)  of the Act. 
(c) 1999  c.28. 
(d) “place  on the market”  has the meaning  in section  30(3)  of the Act. 
10 (a) a marketable  precision  bred organism (a); or 
(b) the qualifying  progeny (b) of a marketable  precision  bred organism. 
(3) Before  the Secretary  of State  can issue  a marketing  authorisation  under  this Part, the following 
requirements  must  be satisfied— 
(a) any food or feed produced  from  the organism  and covered  by the marketing  authorisation 
will not have  adverse  effects  on animal  or human  health; 
(b) the way in which  any such food or feed will be placed  on the market  will not mislead 
consumers; 
(c) the production  of any such food or feed in place  of other  food or feed will 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  will not be nutritionally  disadvantageous  to humans  or animals. 
(4) An application  for a marketing  authorisation  under  this Part may include  more  than one 
precision  bred organism  if all the precision  bred organisms  are covered  by the same  precision 
bred confirmation (c). 
(5) An applicant  must  apply  for a marketing  authorisation  under  the process  set out in regulation 
21 (“Tier 2”) if— 
(a) the criteria  set out in regulation  20(1)(c)  are not met; or 
(b) the applicant  is uncertain  whether  the criteria  are met. 
(6) If the criteria  in regulation  20(1)(c)  are met, an application  may be made  under  the process 
set out in regulation  20 (“Tier 1”). 
(7) An applicant  may withdraw  an application  for a marketing  authorisation  at any time by 
giving  a request  to the Food  Standards  Agency . 
(8) Subject  to regulation  26, the Food  Standards  Agency  must  publish  on its website  marketing 
authorisation  applications  which  have  been  verified  in accordance  with— 
(a) regulation  20(5)(c)  for a Tier 1 marketing  authorisation  application;  or 
(b) regulation  22(1)(c)  for a Tier 2 marketing  authorisation  application. 
(9) For the purposes  of this Part, the following  functions  are conferred  on the Food  Standards 
Agency— 
(a) the review  of marketing  authorisation  applications; 
(b) the publication  of marketing  authorisation  applications; 
(c) the determination  of commercially  confidential  information  under  regulation  26; 
(d) the performance  of risk assessments  and risk management  assessments; 
(e) making  requests  for additional  information  under  regulation  22; 
(f) the preparation  of a report  for the Secretary  of State  under  regulation  22; 
(g) the obtaining  of advice  from  a Food  Standards  Advisory  Committee  or such other  persons 
with the relevant  expertise; 
(h) the communication  of the Secretary  of State’ s decision  to the applicant  under  regulation 
23. 
(a) “marketable  precision  bred organism”  is defined  in section  5(2) of the Act. 
(b) “qualifying  progeny”  is defined  in section  24 of the Act. 
(c) see section  8 of the Act. 
11 Application  for a Tier 1 food  and feed marketing  authorisation 
20. —(1) An applicant  may apply  for a Tier 1 marketing  authorisation  in circumstances  where— 
(a) the precision  bred organism  has a precision  bred confirmation  issued  by the Secretary 
of State  under  section  8 of the Act; 
(b) the applicant  is able to demonstrate,  if asked  to do so, that the requirements  in regulation 
19(3)  are satisfied;  and 
(c) the applicant  is able to demonstrate  that the relevant  precision  bred organism— 
(i) is from  a species  that has a significant  prior  history  of safe consumption  in the UK 
or EU, 
(ii) does not introduce  significant  changes  to the nutritional  quality  of the organism 
currently  consumed  that are likely  to be disadvantageous  to the consumer , 
(iii) does not introduce  significant  changes  that are expected  to elevate  the toxicity  of 
any food or feed produced  from  the precision  bred organism, 
(iv) does not introduce  significant  changes  that are expected  to alter the allergenicity 
of any food or feed produced  from  the precision  bred organism,  and 
(v) does not have  any additional  features  that cause  food or feed safety  concerns. 
(2) An applicant  may apply  for a Tier 1 marketing  authorisation  by giving  the Food  Standards 
Agency  a marketing  authorisation  application. 
(3) The marketing  authorisation  application  must  contain  the information  required  in paragraph 
1 of Schedule  4 to these  Regulations. 
(4) The information  required  in paragraph  (3) must  be given  to the extent  and level  of detail 
that such information  is appropriate  to the nature  and scale  of the application. 
(5) Upon  receipt  of a marketing  authorisation  application  under  paragraph  (2), the Food  Standards 
Agency  must,  as soon  as reasonably  practicable— 
(a) acknowledge  receipt  of the marketing  authorisation  application; 
(b) allocate  a unique  reference  number  to the marketing  authorisation  application; 
(c) verify  that the requirements  of paragraph  (3) are met. 
(6) Where  the requirements  of paragraph  (3) are not met, the Food  Standards  Agency  must 
advise  the applicant  that the application  is invalid. 
(7) The Food  Standards  Agency  may request  the applicant  provide  additional  information, 
including  evidence,  in support  of their application,  if required. 
(8) Where  the Food  Standards  Agency  has requested  additional  information  under  paragraph 
(7), the applicant  must  provide  that information  within  any time period  specified  by the Food 
Standards  Agency . 
(9) If the additional  information  requested  under  paragraph  (7) is not supplied  within  the time 
period  in paragraph  (8), the application  will be treated  as withdrawn. 
(10) Where  the application  has been completed  in compliance  with the requirements  of paragraph 
(3), the Food  Standards  Agency  must  report  to the Secretary  of State  — 
(a) that it considers  that a marketing  authorisation  should  be issued; 
(b) any other  relevant  matters. 
(11) Upon  receipt  of a report  from  the Food  Standards  Agency  under  paragraph  (10),  the 
Secretary  of State  must  follow  the authorisation  process  set out in regulation  23. 
12 Application  for a Tier 2 food  and feed marketing  authorisation 
21. —(1) An applicant  may apply  for a Tier 2 marketing  authorisation  in circumstances  where— 
(a) the precision  bred organism  has a precision  bred confirmation  issued  by the Secretary 
of State  under  section  8 of the Act; 
(b) the applicant  is able to demonstrate,  if asked  to do so, that the requirements  in regulation 
19(3)  are satisfied; 
(c) the applicant  reasonably  concludes  that any of the criteria  set out in paragraph  20(1)(c) 
are not met. 
(2) If an applicant  is uncertain  whether  the criteria  in regulation  20(1)(c)  are met, the person 
must  make  an application  under  this regulation. 
(3) An applicant  may apply  for a Tier 2 marketing  authorisation  by giving  the Food  Standards 
Agency  a marketing  authorisation  application  containing  the information  required  in Schedule  4 
to these  Regulations. 
(4) The information  required  under  paragraph  (3) must  be given  to the extent  and the level  of 
detail  that such information  is appropriate  to the nature  and scale  of the application. 
(5) The notice  may contain  — 
(a) any other  information  that the person  making  the application  considers  relevant; 
(b) any information  from  any previous  application  by some  other  person  under  this Part 
provided  that the agreement  in writing  of those  other  persons  is obtained. 
Assessment  by the Food  Standards  Agency 
22. —(1) Upon  receipt  of an application  under  regulation  21, The Food  Standards  Agency 
must— 
(a) acknowledge  receipt  of the application; 
(b) allocate  a unique  reference  number  to the application; 
(c) verify  that the requirements  of regulation  21(3)  are met; 
(2) Where  the requirements  of regulation  21(3)  are not met, the Food  Standards  Agency  must 
advise  the applicant  that the application  is invalid. 
(3) The Food  Standards  Agency  may request  the applicant  provide  additional  information, 
including  evidence,  in support  of their application,  if required. 
(4) Where  the Food  Standards  Agency  has requested  additional  information  under  paragraph 
(3), the applicant  must  provide  that information  within  any time period  specified  by the Food 
Standards  Agency . 
(5) If the additional  information  requested  under  paragraph  (3) is not supplied  within  the time 
period  in paragraph  (4), the application  will be treated  as withdrawn. 
(6) Having  completed  the steps  in paragraph  (1), including  any request  for additional  information 
under  paragraph  (3), the Food  Standards  Agency  must  carry  out a risk assessment  of the application 
having  particular  regard  to those  criteria  set out in regulation  20(1)(c)  that are not met. 
(7) When  considering  a marketing  authorisation  application,  the Food  Standards  Agency  may 
require  the applicant  to provide  additional  information,  including  evidence,  in support  of their 
application. 
(8) Where  the Food  Standards  Agency  has requested  additional  information  under  paragraph 
(7), the applicant  must  provide  that information  within  any time period  specified  by the Food 
Standards  Agency . 
13 (9) If the additional  information  requested  under  paragraph  (7) is not supplied  within  the time 
period  in paragraph  (8), the application  will be treated  as withdrawn. 
(10) The Food  Standards  Agency  may consult  or request  advice  or information  in relation  to 
the marketing  authorisation  application  from  a Food  Standards  Advisory  Committee. 
(11) The Food  Standards  Agency  may consult  or request  advice  or information  from  such other 
persons  with the relevant  expertise  as necessary  to enable  them  to conduct  a risk assessment 
under  paragraph  (6). 
(12) The Food  Standards  Agency  must  forward  to any committee,  other  advisory  body  or person 
that it consults  or requests  advice  or information  from  under  paragraphs  (10) or (11) the following 
information— 
(a) the marketing  authorisation  application; 
(b) any risk assessment  carried  out in relation  to the application; 
(c) any other  relevant  information. 
(13) Any advice  or information  provided  under  paragraphs  (10) or (11) must  be provided  without 
undue  delay . 
(14) Subject  to regulation  26, any advice  or information  provided  under  paragraphs  (10) or (11) 
must  be published. 
(15) Any obligations  imposed  on any committee,  other  advisory  body  or persons  under  paragraphs 
(10) or (11) are not Part 3 obligations (a). 
(16) 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 Food  Standard  Agency’ s risk assessment  including  any 
recommendations  to the Secretary  of State  arising  from  it; 
(b) whether  the requirements  under  regulation  19(3)  are satisfied; 
(c) a risk management  assessment  of other  legitimate  factors  relevant  to the application 
under  consideration; 
(d) whether  the 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. 
Food  and feed marketing  authorisations 
23. —(1) Upon  receipt  of a report  from  the Food  Standards  Agency  under  regulations  20 or 
22, the Secretary  of State  must  decide— 
(a) whether  to grant  a marketing  authorisation; 
(b) any conditions  that must  attach  to the marketing  authorisation; 
(c) any limitations  that must  attach  to the marketing  authorisation. 
(2) The Secretary  of State  must  advise  the Food  Standards  Agency  of the decisions  under 
paragraph  (1) as soon  as reasonably  practicable  following  receipt  of the report  from  the Food 
Standards  Agency . 
(a) see section  29(3)(b)  of the Act. 
14 (3) If not satisfied  that a marketing  authorisation  should  be granted,  the Secretary  of State  must 
give reasons  for the decision. 
(4) The Food  Standards  Agency  must  advise  the applicant  of the Secretary  of State’ s decisions 
under  paragraph  (1) as soon  as reasonably  practicable  following  receipt  of the decision. 
(5) The notification  under  paragraph  (4) must  include  the following  information— 
(a) the decision; 
(b) any conditions  that attach  to the marketing  authorisation; 
(c) any limitations  that attach  to the marketing  authorisation. 
(6) The Secretary  of State  must  not give a marketing  authorisation  in the following 
circumstances— 
(a) if the required  information  has not been  provided  by the applicant; 
(b) if the requirements  in regulation  19(3)  are not satisfied; 
(c) if there  are other  legitimate  factors  which  do not support  a decision  to authorise; 
(d) If an application  has been  made  under  regulation  20 and the Secretary  of State  considers 
that the process  in regulation  21 is the appropriate  process  for the marketing  authorisation 
notice. 
(7) If the Secretary  of State  refuses  a marketing  authorisation,  a summary  of the recommendation 
provided  to the Secretary  of State  by the Food  Standards  Agency  must  be published  by the Food 
Standard  Agency  on its website. 
(8) The Food  Standards  Agency  must  enter  the decision  made  under  this regulation  and other 
required  information  to the Food  and Feed  Register  in accordance  with regulation  27. 
(9) Upon  application  by the applicant  or authorisation-holder , the Secretary  of State  may decide 
to add, cancel  or vary conditions  or limitations  to a marketing  authorisation  at any time. 
Duties  on authorisation-holders 
24. —(1) After  a marketing  authorisation  has been  issued  in accordance  with regulation  23, the 
authorisation  holder  must  comply  with any conditions  or limitations  which  have  been  included 
in the marketing  authorisation. 
(2) The authorisation-holder  and other  persons  authorised  by the marketing  authorisation  to 
place  the food and feed that is the subject  of the marketing  authorisation  on the market  must 
ensure  that precision  bred organisms  are not marketed  in a way that is not in accordance  with 
the marketing  authorisation. 
(3) If the authorisation-holder  proposes  to amend  the terms  of the marketing  authorisation,  the 
authorisation  holder  must  apply  to the Secretary  of State  in accordance  with regulation  21(3). 
(4) An authorisation-holder  must  advise  the Food  Standards  Agency  immediately  if they become 
aware  of changes  in circumstances  that affect the marketing  authorisation. 
Revocation  or variation  of a food  and feed marketing  authorisation 
25. —(1) The Secretary  of State  may consider  the revocation  or variation  of a marketing 
authorisation  in the following  circumstances— 
(a) if the Food  Standards  Agency  or the Secretary  of State  becomes  aware  of any new 
scientific  or technical  information  which  might  influence  the evaluation  of the safety  of 
use or quality  of the precision  bred organism  for use as food or feed; 
15 (b) if the Food  Standards  Agency  or the Secretary  of State  become  aware  of any other 
information  which  might  influence  the evaluation  of the safety  of use or quality  of the 
precision  bred organism  for use as food or feed. 
(c) an authorisation-holder  of their own accord  is not satisfied  that the product  covered  by 
the marketing  authorisation  meets  the conditions  or limitations  of the marketing 
authorisation  or the authorisation  is no longer  required; 
(2) When  information  is made  available  to either  the Food  Standards  Agency  or the Secretary 
of State  in accordance  with paragraph  (1)(a)  or (b), the authorisation-holder  may be given  the 
opportunity  to respond  to the information  made  available  under  paragraph  (1)(a)  or (b) within  a 
reasonable  time period. 
(3) When  information  is made  available  under  paragraph  (1), the Food  Standards  Agency  may 
on its own initiative  or at the request  of the Secretary  of State  prepare  a report  for the Secretary 
of State  assessing  whether  the precision  bred organism  for use in food or feed continues  to meet 
the requirements  of the marketing  authorisation. 
(4) Upon  receipt  of a report  under  paragraph  (3), the Secretary  of State  may take any appropriate 
measures,  which  may include  the variation  or revocation  of the marketing  authorisation  or revoking, 
adding  to or varying  any limitations  or conditions  attaching  to the marketing  authorisation. 
(5) A decision  to revoke  a marketing  authorisation  under  paragraph  (4) may include  transitional 
arrangements  to allow  for the removal  of products  from  the market  or other  good  reason. 
(6) The Food  Standards  Agency  must  update  the Food  and Feed  Register  in accordance  with 
regulation  27. 
Confidentiality 
26. —(1) An applicant  may request  confidential  treatment  of certain  commercial  information 
submitted  under  this Part where  disclosure  of such information  may harm  their competitive  position 
(2) For the purposes  of paragraph  (1) applicants  must  indicate  which  parts  of the information 
provided  they wish  to be treated  as commercially  confidential  in accordance  with paragraph  1(5) 
of Schedule  4 to these  Regulations. 
(3) Upon  receipt  of a request  under  paragraph  (2), the Food  Standards  Agency  must  determine 
which  information  is to be treated  as commercially  confidential  and notify  the applicant  of its 
decision. 
(4) Paragraph  (3) ceases  to apply  if the Food  Standards  Agency  determines  that the information 
is no longer  commercially  confidential  (whether  or not on request  by a person). 
(5) The following  information  must  not be considered  commercially  confidential— 
(a) the information  set out in regulation  27(1); 
(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  received  by them  under  this Part 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 commercial  information,  including  research  and development 
information,  as well as any information  in respect  of which  a claim  of confidentiality  is disputed. 
(8) The application  of paragraphs  (1) to (7) does not affect the exchange  of information  between 
the Food  Standards  Agency  and the Secretary  of State. 
16 PART 8 
The Food  and Feed  Register 
Food  and feed marketing  authorisations  register 
27. —(1) The Food  Standards  Agency  must  establish  and maintain  a marketing  authorisations 
register  (the “Food  and Feed  Register”)  containing  the following  information  — 
(a) the name  of the precision  bred organism  authorised  for use in food and feed; 
(b) the unique  reference  number  (URN)  for the authorised  precision  bred organism; 
(c) the name  and address  of the authorisation-holder; 
(d) the date of the marketing  authorisation; 
(e) the purpose  of the genetic  change  to the precision  bred organism; 
(f) any conditions  or limitations  attached  to the marketing  authorisation; 
(g) a summary  of the risk assessment  carried  out under  regulation  22(4); 
(h) a link to the relevant  entry  on the Precision  Breeding  Register  confirming  the status  of 
the precision  bred organism. 
(i) any revocations  attached  to the marketing  authorisation; 
(j) any withdrawn  marketing  authorisations. 
(2) The information  required  in paragraph  1(a) to (h) must  be added  to the Food  and Feed 
register  as soon  as reasonably  practicable  after the marketing  authorisation  has been  issued. 
(3) The information  requested  under  paragraph  1(i) must  be added  to the Food  and Feed  register 
as soon  as reasonably  practicable  after the revocation  has been  issued. 
(4) The information  requested  under  paragraph  1(j) must  be added  to the Food  and Feed  register 
as soon  as reasonably  practicable  after the marketing  authorisation  is withdrawn. 
(5) The Food  Standards  Agency  must  ensure  that the register  is accessible  to the public  free 
of charge by electronic  means. 
PART 9 
Monitoring  and Inspection  of Food  and Feed  Marketing  Authorisations 
Enfor cement  authorities 
28. The following  are designated  enforcement  authorities  for the purposes  of 28(1)  of the Act— 
(a) Food  Standards  Agency (a); 
(b) “Food  authorities”  which  has the same  meaning  as set out in section  5(1) and (3) of the 
Food  Safety  Act 1990 (b) except  that it does not include  the appropriate  Treasurer  referred 
to in section  5(1)(c)  of that Act (which  deals  with the Inner  Temple  and Middle  Temple); 
(c) “Feed  authorities”  which  means  an authority  identified  in section  67(1)  of the Agriculture 
Act 1970 (c) as having  the duty to enforce  Part IV of that Act within  its area or district 
(a) See section1  of the Food  Standards  Act 1999  c. 28. 
(b) 1990  c. 16. 
(c) 1970  c. 40. 
17 as the case may be and unless  the context  otherwise  requires  any reference  to Part IV 
in that section  must  be construed  as a reference  to Part 3 of the Act. 
Inspectors 
29. —(1) In this Part, “inspector”  means  an inspector  appointed  by an enforcement  authority 
designated  under  regulation  28. 
(2) An inspector  under  paragraph  (1), has the following  functions— 
(a) monitoring  compliance  with Part 3 obligations; 
(b) investigating  suspected  failures  to comply  with Part 3 obligations. 
(3) An inspector  appointed  under  this Part is not liable  in any civil or criminal  proceedings  for 
anything  done  in the purported  exercise  of the inspector ’s functions  under  this Part or Part 10 if 
the court  is satisfied  that the act was done  in good  faith and that there  were  reasonable  grounds 
for doing  it. 
(4) Relief  from  liability  of an inspector  under  paragraph  (3) does not affect any liability  of any 
other  person  in respect  of the inspector ’s act. 
Part  3 obligation 
30. In these  Regulations,  references  to a failure  to comply  with a Part 3 obligation  include 
references  to providing  or recording  information,  or making  a statement,  that is false  or 
misleading— 
(a) in purported  compliance  with a Part 3 obligation,  or 
(b) in connection  with any application  or review , or any proposal  to revoke  or vary a 
marketing  authorisation  or to vary, revoke  or impose  conditions  or limitations  under 
Part 3 of the Act. 
Inspection 
31. —(1) For the purposes  of carrying  out their functions,  inspectors  may— 
(a) on producing,  if so required,  some  duly authenticated  document  confirming  the inspector ’s 
authority; 
(b) at any reasonable  hour; 
(c) enter  any land or premises,  other  than a private  dwelling. 
(2) Inspectors  must  inform  the owner  or occupier  or person  who has control  of the land or 
premises  of the purpose  of the proposed  inspection  and, where  possible,  agree  a suitable  date and 
time for that inspection. 
(3) Where  it is not possible  to agree  a suitable  date and time,  the inspector  must  notify  the 
owner  or occupier  or person  who has control  of the land or premises  of the purpose  of the 
inspection  and the date and time at least 48 hours  in advance  of that inspection. 
Powers  of entry 
32. —(1) An inspector  may, at any reasonable  hour, enter  any land or premises,  other  than a 
private  dwelling,  without  notice,  if— 
(a) there  is a reasonable  suspicion  of— 
(i) a failure  to comply  with a Part 3 obligation, 
(ii) an offence  having  been committed  under  any other  legislation  insofar  as it is relevant 
to a Part 3 obligation; 
18 (b) the inspector  produces,  if so required,  a duly authenticated  document  confirming  the 
inspector ’s authority;  and 
(c) one of the conditions  in paragraph  (4) is met. 
(2) An inspector  may, at any reasonable  hour, enter  any private  dwelling  without  notice  if a 
warrant  has been  obtained  in accordance  with paragraph  (3). 
(3) A justice  of the peace  may, by signed  warrant,  permit  an inspector  to enter  any private 
dwelling,  if necessary  by reasonable  force,  if the justice  on sworn  information  in writing  is 
satisfied  that— 
(a) there  is a reasonable  basis  for the suspicion  under  paragraph  (1)(a); 
(b) one or more  of the conditions  in paragraph  (4) is met; and 
(c) if only the condition  in paragraph  (4)(a)  is met— 
(i) notice  of intention  to apply  for a warrant  has been  served  on the owner  or occupier 
or other  person  with control  of the property , or 
(ii) such notice  has not been  served  because  serving  such a notice  would  interfere  with 
the purpose  or effectiveness  of the entry . 
(4) The conditions  are that— 
(a) entry  to the land or premises  has been  refused  or the Secretary  of State  has reasonable 
grounds  to suspect  that entry  is likely  to be refused; 
(b) entry  is required  urgently; 
(c) the land or premises  are unoccupied  or the occupier  is temporarily  absent. 
(5) A warrant  signed  in accordance  with paragraph  (3) is valid  for one month  from  the date of 
the signature. 
(6) An inspector  who enters  any land or premises  which  are unoccupied  or from  which  the 
occupier  is temporarily  absent  must  leave  them  as effectively  secured  as they were  before  entry . 
Powers  of inspection 
33. —(1) An inspector  who carries  out an inspection  of land or premises  in accordance  with 
regulations  31 or 32, may— 
(a) inspect  and search  premises; 
(b) undertake  examination,  search  and seizure  of property; 
(c) take copies  of documents; 
(d) take photographs  and samples; 
(e) impose  requirements; 
(f) require  the provision  of information. 
(2) Inspectors  may be accompanied  by such other  persons  as the inspector  considers  necessary 
in carrying  out their functions  under  this Part. 
(3) the owner  or occupier  of the land or premises  or such other  person  with control  of the 
premises,  or the employee  or agent  of that person  must  give the inspector  such assistance  as the 
authorised  person  may reasonably  request. 
19 PART 10 
Enforcement  of relevant  breaches 
Relevant  breaches 
34. —(1) This Part applies  in relation  to the enforcement  of relevant  breaches (a) under  Part 4 
of the Act. 
(2) For the purposes  of the Act and these  Regulations,  the following  matters  are treated  as 
relevant  breaches— 
(a) obstructing  an inspector; 
(b) providing  false  information  to an inspector; 
(c) impersonating  an inspector . 
(3) Where  a person  has failed  to comply  with a Part 3 obligation  due to an act or default  of 
some  other  person,  that other  person  may be treated  as having  failed  to comply  with the Part 3 
obligation. 
(4) Enforcement  action  may be taken  against  the other  person  referred  to in paragraph  (2) 
whether  or not action  is taken  against  the first-mentioned  person. 
(5) A failure  to comply  with a Part 3 obligation  is not to be regarded  as a relevant  breach  where 
the person  can prove  that— 
(a) they took all reasonable  precautions  and exercised  all due diligence  to avoid  the failure 
to comply  with the Part 3 obligation  by themselves  or by a person  under  their control; 
(b) In paragraph  (a), a person  who neither— 
(i) prepared  the food or feed in respect  of which  the relevant  breach  is alleged  to have 
occurred,  or 
(ii) imported  it into Great  Britain, 
must  be taken  to have  established  the defence  in paragraph  (a) if they satisfy  the 
requirements  in sub-paragraphs  (c) or (d); 
(c) a person  satisfies  the requirements  of this sub-paragraph  if they prove— 
(i) that the failure  to comply  with the Part 3 obligation  was due to an act or default 
of another  person  who was not under  their control,  or to reliance  on information 
supplied  by such a person, 
(ii) that they carried  out all such checks  of the food or feed in question  as were 
reasonable  in all the circumstances,  or that it was reasonable  in all the circumstances 
for them  to rely on checks  carried  out by the person  who supplied  the food or feed 
to him; 
(iii) that they did not know  and had no reason  to suspect  at the time of the alleged 
failure  to comply  with the Part 3 obligation  that the act or omission  would  amount 
to a failure  to comply  with the Part 3 obligation; 
(d) a person  satisfies  the requirements  of this sub-paragraph  if they prove— 
(i) that the failure  to comply  with the Part 3 obligation  was due to an act or default 
of another  person  who was not under  their control,  or to reliance  on information 
supplied  by such a person, 
(a) “relevant  breach”  has the meaning  in section  31 of the Act. 
20 (ii) that the sale or intended  sale of which  the alleged  failure  to comply  with a Part 3 
obligation  was not a sale or intended  sale under  their name  or mark,  and 
(iii) that they did not know , and could  not reasonably  have  been  expected  to know , at 
the time of the alleged  failure  to comply  with the Part 3 obligation  that their act 
or omission  would  amount  to a failure  to comply  with the Part 3 obligation  under 
the relevant  provision. 
(6) A failure  to comply  with a Part 3 obligation  is not to be regarded  as a relevant  breach  where 
the person  can prove  that— 
(a) they are a person  whose  business  it is to publish  or arrange  for the publication  of 
advertisements;  and 
(b) that they received  the advertisement  in the ordinary  course  of business  and did not know 
and had no reason  to suspect  that its publication  would  amount  to a failure  to comply 
with a Part 3 obligation. 
Enfor cement  notices 
35. —(1) An inspector  may issue  either  of the following  enforcement  notices  in relation  to a 
relevant  breach— 
(a) compliance  notice; 
(b) stop notice. 
(2) A monetary  penalty  notice  in relation  to a relevant  breach  may be issued  by— 
(a) the Secretary  of State; 
(b) an inspector . 
Content  of enfor cement  notices 
36. —(1) An enforcement  notice  issued  under  regulation  35 must  state— 
(a) the grounds  for issuing  the notice,  which  must  include— 
(i) the relevant  obligation  to which  the relevant  breach  relates,  and 
(ii) the matters  which,  in the opinion  of the inspector  or Secretary  of State  issuing  the 
notice,  constitute  the failure  to comply  with that obligation. 
(b) the person’ s rights  to require  a review  of or appeal  against  the notice; 
(c) the consequences  of a failure  to comply  with the notice. 
(2) A notice  issued  under  this Part may be revoked  or varied— 
(a) by the Secretary  of State,  in the case of a monetary  penalty  notice  issued  by the Secretary 
of State; 
(b) by an inspector  in any other  case. 
Compliance  notices 
37. —(1) A compliance  notice  issued  under  regulation  35(1)  may be issued  only where  the 
inspector  issuing  the notice  is satisfied  that the person  to whom  it is issued  has committed  or is 
committing  a relevant  breach. 
(2) The steps  specified  in the compliance  notice  must  be steps  that the inspector  considers  will 
ensure  that the relevant  breach  does not continue  or recur . 
(3) The period  specified  in the compliance  notice  must  be not less than 14 days beginning  with 
the date on which  the notice  is received. 
21 Stop  notices 
38. —(1) A stop notice  issued  under  regulation  35(1)  may be issued  only where  the inspector 
issuing  the notice  reasonably  believes  that the person  to whom  it is issued  has committed  or is 
likely  to commit  a relevant  breach. 
(2) The inspector  issuing  the stop notice  must  consider  that the steps  specified  in the stop notice 
are steps  that will ensure  the specified  activity  will be carried  on in a way that does not involve 
the person  committing  a relevant  breach. 
(3) Where  the Secretary  of State  considers  it necessary  or expedient  to enforce  the stop notice, 
the Secretary  of State  may apply  to the court  for an injunction. 
(4) An application  for an injunction  under  paragraph  (3) may be made  without  notice. 
Monetary  penalty  notices 
39. —(1) The Secretary  of State  or an inspector  may issue  a monetary  penalty  notice  under 
regulation  35(2)  only where  satisfied  that the person  to whom  it is issued  has committed  a relevant 
breach. 
(2) The amount  of any monetary  penalty  must  be determined  by the Secretary  of State  or an 
inspector . 
(3) The monetary  penalty  notice  must  state— 
(a) how payment  may be made; 
(b) the period  within  which  payment  must  be made; 
(c) the consequences  of late payment  or failure  to pay. 
(4) Where  interest  is payable  on late payment  of a monetary  penalty , the notice  must  state the 
interest  to be paid as follows— 
(a) Interest  is payable  on the amount  of any monetary  penalty  for each day from  the end 
of the period  for payment  specified  in the notice  to the date on which  the sum specified 
in the monetary  penalty  notice  is paid. 
(b) For the purposes  of paragraph  (a), the rate of interest  applicable  on any day is one 
percentage  point  above  the Bank  of England  base rate. 
(c) In paragraph  (b) “Bank  of England  base rate”  means— 
(i) except  where  sub-paragraph  (ii) applies,  the rate announced  from  time to time by 
the Monetary  Policy  Committee  of the Bank  of England  as the official  dealing  rate, 
being  the date at which  the Bank  is willing  to enter  into transactions  for providing 
short  term liquidity  in the money  markets,  or 
(ii) if an order  under  section  19 of the Bank  of England  Act 1998 (a)(reserve  powers) 
is in force,  any equivalent  rate determined  by the Treasury  under  that section. 
(5) Amounts  payable  under  this regulation,  including  the monetary  penalty , and any interest  or 
other  penalty  for late payment  are recoverable  as a civil debt. 
Review  of enfor cement  notices 
40. —(1) A person  to whom  an enforcement  notice  is issued  under  this Part may require  the 
Secretary  of State  to review  the decision  to issue  the notice. 
(2) A request  for a review  under  paragraph  (1) must  be made  within  28 days of the date of 
receipt  of the notice. 
(a) 1998  c. 11. 
22 (3) The grounds  for a review  under  paragraph  (1) are— 
(a) that the decision  was based  on an error  of fact; 
(b) that the decision  was wrong  in law; 
(c) that any steps  specified  in the notice  were  unreasonable; 
(d) in the case of a stop notice,  that the person  to whom  it was issued  had not committed 
the relevant  breach  and would  not have  done  so had the notice  not been  issued; 
(e) in the case of a monetary  penalty  notice,  that the amount  of the penalty  was unreasonable; 
(f) that the decision  was unreasonable  for any other  reason. 
(4) The Secretary  of State  may give due regard  to any additional  information  or evidence 
provided  by the person  making  the request  under  paragraph  (1). 
(5) On review  of an enforcement  notice,  the Secretary  of State  must— 
(a) decide  whether  to uphold,  vary or revoke  the notice; 
(b) give notice  to the person  who requested  the review , within  a reasonable  period,  setting 
out— 
(i) the Secretary  of State’ s decision, 
(ii) the reasons  for that decision, 
(c) inform  the person  of the right  to appeal  to the First-tier  tribunal. 
(6) The Secretary  of State  may suspend  the operation  of any compliance  notice  or monetary 
penalty  notice  to which  the review  relates  pending  the outcome  of the review . 
Appeal  against  enfor cement  notices 
41. —(1) If not satisfied  with the outcome  of a review  under  regulation  40, a person  may appeal 
the decision  to issue  the notice  to the First-tier  Tribunal. 
(2) An appeal  must  be made  within  28 days of the date of receipt  of the Secretary  of State’ s 
notice  issued  under  regulation  40(5). 
(3) The grounds  for an appeal  under  paragraph  (1) are — 
(a) that the decision  was based  on an error  of fact; 
(b) that the decision  was wrong  in law; 
(c) that any steps  specified  in the notice  were  unreasonable; 
(d) in the case of a stop notice,  that the person  to whom  it was issued  had not committed 
the relevant  breach  and would  not have  done  so had the notice  not been  issued; 
(e) in the case of a monetary  penalty  notice,  that the amount  of the penalty  was unreasonable; 
(f) that the decision  was unreasonable  for any other  reason. 
(4) The First-tier  Tribunal  may give due regard  to any additional  information  or evidence 
provided  by the person  making  the appeal  under  paragraph  (1). 
(5) The First-tier  Tribunal  may— 
(a) uphold  the enforcement  notice; 
(b) vary the enforcement  notice; 
(c) revoke  the enforcement  notice; 
(d) take such steps  as the Secretary  of State  could  take in relation  to the notice; 
(e) remit  the decision  whether  to confirm  the notice,  or any matter  relating  to that decision, 
to the Secretary  of State. 
23 (6) The First-tier  Tribunal  may suspend  the operation  of any compliance  notice  or monetary 
penalty  notice  to which  the appeal  relates  pending  the outcome  of the appeal. 
Costs 
42. —(1) An appropriate  authority (a) may issue  a costs  notice  requiring  a person  to pay the 
costs  incurred  by the authority  in relation  to an enforcement  notice  up to the time of its issue. 
(2) A costs  notice  must  specify  the amount  required  to be paid which  may include— 
(a) investigation  costs; 
(b) administration  costs; 
(c) costs  of obtaining  expert  advice  (including  legal  advice). 
(3) Where  interest  is payable  on late payment  of a costs  notice,  the notice  must  state the interest 
to be paid as follows— 
(a) Interest  is payable  on the amount  of any costs  notice  for each day from  the end of the 
period  for payment  specified  in the notice  to the date on which  the sum specified  in the 
costs  notice  is paid. 
(b) For the purposes  of paragraph  (a), the rate of interest  applicable  on any day is one 
percentage  point  above  the Bank  of England  base rate. 
(c) In paragraph  (b) “Bank  of England  base rate”  means— 
(i) except  where  sub-paragraph  (ii) applies,  the rate announced  from  time to time by 
the Monetary  Policy  Committee  of the Bank  of England  as the official  dealing  rate, 
being  the date at which  the Bank  is willing  to enter  into transactions  for providing 
short  term liquidity  in the money  markets,  or 
(ii) if an order  under  section  19 of the Bank  of England  Act 1998  (reserve  powers)  is 
in force,  any equivalent  rate determined  by the Treasury  under  that section. 
(4) A person  to whom  a costs  notice  is issued  may require  the person  issuing  it to provide  a 
detailed  breakdown  of the amount  in paragraph  (2). 
(5) A person  to whom  a costs  notice  is issued  is not liable  to pay any costs  which  that person 
shows  have  been  unnecessarily  incurred. 
(6) Amounts  payable  by virtue  of this regulation,  including  the costs  and any interest  or other 
penalty  for late payment  are recoverable  as a civil debt. 
Review  and appeal  of costs  notices 
43. —(1) A person  to whom  a costs  notice  has been  issued  may— 
(a) require  the Secretary  of State  to review  the relevant  decision (b); and 
(b) if not satisfied  with the outcome  of the review , appeal  against  the relevant  decision  in 
accordance  with paragraph  (4). 
(2) The grounds  on which  a review  may be required  or an appeal  brought  are— 
(a) in the case of a decision  as to the amount  of the costs,  that the amount  includes  any 
amount  referable  to any costs  unnecessarily  incurred; 
(b) that the decision  was based  on an error  of fact; 
(c) that the decision  was wrong  in law; and 
(d) that the decision  was unreasonable  for any other  reason. 
(a) “appropriate  authority”  has the meaning  in section  38(2)  of the Act. 
(b) “Relevant  decision”  has the meaning  in section  38(6)  of the Act. 
24 (3) A review  under  paragraph  (1)(a)  must  be requested  in writing  within  28 days of the date 
of the costs  notice. 
(4) An appeal  under  paragraph  (1)(b)  must  be brought  to the First-tier  Tribunal  within  28 days 
of the date of the review  decision  made  under  paragraph  (1)(a). 
(5) The operation  of any costs  notice  is suspended  where  an appeal  is brought  under  this 
regulation  pending  the outcome  of the appeal. 
PART 11 
General 
Notices 
44. In these  Regulations,  a notice  or other  document  is— 
(a) to be given  or issued  in writing  which  includes  by electronic  means; 
(b) to be treated  as being  received  when  the sender  receives  a dated  confirmation  of receipt 
from  the intended  recipient  either  through  an automated  email  response  if received  by 
email  or by otherwise  sending  an email  acknowledgement  of receipt  to the sender . 
Consequential  Amendments 
45. Schedule  5 sets out consequential  amendments  to legislation  in respect  of England  to the 
extent  specified  in that Schedule. 
Name 
Parliamentary  Under  Secretary  of State 
Department  for Environment,  Food  and Rural  Affairs 
25 SCHEDULES 
Regulation  3(3) SCHEDULE  1 
Information  that must  be provided  to the Secretary  of State  in a release 
notice 
1. Name,  address,  telephone  number  and email  address  of the person  who is proposing  to release 
the precision  bred organism  from  under  their control. 
2. Where  the person  whose  details  are provided  in paragraph  (1) is an organisation,  the name, 
position,  address,  telephone  number  and email  address  of an employee  or agent  of that organisation 
who may be contacted  in relation  to the release  notice. 
3. A description  of other  persons  who may assist  in the release  of the precision  bred organism. 
4. A general  description  of the precision  bred organism  in accordance  with Schedule  3. 
5. Confirmation  that the person  responsible  for the release— 
(a) will put in place  appropriate  measures,  as necessary , to prevent  material  from  the precision 
bred organism  being  marketed  until such time as a precision  bred confirmation  is issued 
is respect  of the organism;  and 
(b) has assessed  that all organisms  covered  by the release  notice  meet  the criteria  for a 
precision  bred organism  set out in section  1 of the Act. 
Regulation  5(2) SCHEDULE  2 
Information  that must  be provided  to the Secretary  of State  in a marketing 
notice 
1. The name,  organisation  name,  address,  email  address  and telephone  number  of— 
(a) the notifier; 
(b) the person  with overall  responsibility  for marketing  the precision  bred organism; 
(c) any representative  of the person  in sub-paragraph  (a). 
2. General  description  of the precision  bred organism  in accordance  with Schedule  3. 
3. A description  of the intended  use of the precision  bred organism. 
4. Information  about  the changes  made  to the precision  bred organism  including— 
(a) any alterations  to characteristics  resulting  from  the application  of modern  biotechnology; 
(b) information  about  the genetic  changes  made  to achieve  characteristics  described  in 
paragraph  (a), including— 
(i) the specific  genetic  changes  made, 
(ii) their location, 
(iii) their genetic  stability , 
(iv) when  the genetic  change  involves  the insertion  of any genetic  material,  a description 
of all the genetic  elements  inserted  and the organisms  from  which  they originated; 
26 5. a description  of how the genetic  changes  were  introduced  into the precision  bred organisms, 
including— 
(a) which  techniques  of modern  biotechnology  were  used, 
(b) if used,  information  about  any transgenic  intermediates. 
6. A description  of the procedures  and analysis  undertaken  to— 
(a) confirm  the precision  bred organisms  only contain  genetic  sequences  that could  arise 
by traditional  processes; 
(b) minimise  the potential  for unintended  genetic  changes  to be present  in the precision 
bred organisms; 
(c) identify  any unintended  genetic  changes  which  are attributable  to the use of modern 
biotechnology , including— 
(i) descriptions  of unintended  genetic  changes  set out as prescribed  in paragraph  4(b), 
(ii) the approach  used to remove  unintended  genetic  changes,  where  this was undertaken. 
7. If the marketing  notice  covers  more  than one precision  bred organism— 
(a) the number  of precision  bred organisms  must  be stated; 
(b) confirmation  must  be provided  that all precision  bred organisms— 
(i) have  the same  characteristics  described  in paragraph  4(a), 
(ii) were  developed  in the same  way as described  in paragraph  5, 
(iii) have  been  analysed  in accordance  with paragraph  6(a); 
(c) variation  in the intended  genetic  changes  introduced  to different  precision  bred organisms, 
which  are relevant  to information  provided  under  paragraph  4(b),  must  be provided; 
(d) variation  in any unintended  genetic  changes  introduced  to different  precision  bred 
organisms  which  are relevant  to information  provided  under  paragraph  6(c) must  be 
provided. 
Regulations  3(5),  10(3) SCHEDULE  3 
General  description  information 
1. The full name  of the organism,  including— 
(a) genus; 
(b) species. 
2. Details  of the precision  bred organism,  including— 
(a) the intended  alterations  to characteristics  of the organism; 
(b) the type or types  of genetic  changes  introduced  to confer  the alterations  described  in 
paragraph  (a); 
(c) the techniques  of modern  biotechnology  used to make  the genetic  changes  described  in 
paragraph  (b). 
27 Regulations  20(3),21(3) SCHEDULE  4 
Information  to be provided  to the Food  Standards  Agency  in a food and 
feed marketing  authorisation  application 
1. —(1) The name,  organisation  name,  address,  email  address  and telephone  number  of— 
(a) the applicant;  and 
(b) any representative  of the person  in sub-paragraph  (a). 
(2) Completed,  unredacted  copies  of the following— 
(a) the relevant  marketing  notice  provided  to the Secretary  of State  under  regulation  5 of 
these  Regulations; 
(b) the documents  supplied  to the Secretary  of State  with the marketing  notice  under 
sub-paragraph  (a); 
(c) the relevant  precision  bred confirmation  issued  by the Secretary  of State; 
(d) where  the precision  bred confirmation  covers  the confirmation  of more  than one precision 
bred organism  in accordance  with regulation  19(4)  of these  Regulations,  a list of the 
individual  precision  bred organisms  and genetic  change  in each precision  bred organism 
must  be provided,  . 
(3) Additional  mandatory  information  as follows— 
(a) the identity  of the precision  bred organism  which  the food or feed is produced  from— 
(i) full name  of the precision  bred organism, 
(ii) genus, 
(iii) species; 
(b) With respect  to the information  provided  under  paragraph  4 of Schedule  2 to these 
Regulations  in the marketing  notice  given  under  Part 2 of the Act, a description  of how 
the genetic  change  introduced  to the precision  bred organism  affects  the edible  part of 
the organism,  including  information  on— 
(i) how the genetic  change  may affect the use of the organism  in food and feed, 
(ii) the identification  of the parts  destined  for use in food and feed, 
(iii) a description  of the intended  use of the precision  bred organism  for food and feed. 
(4) Statements  to demonstrate  how the precision  bred organism  meets  each of the criteria  in 
regulation  20(1)(c)  including  accompanying  descriptive  text setting  out the applicant’ s key 
considerations  and justification  in respect  of each criterion. 
(5) Having  regard  to regulations  26 and 27, if the applicant  is making  a request  that information 
be considered  commercially  confidential,  a statement  setting  out the information  which  the applicant 
wishes  to be considered  commercially  confidential  because  disclosure  may harm  their competitive 
position,  including  the necessary  details  to substantiate  the request.  Verifiable  justification  must 
be given  in such cases. 
2. Additionally , in relation  to a Tier 2 application,  where  the precision  bred organism  does not, 
or may not, meet  one or more  of the criteria  in regulation  20(1)(c)— 
(a) a statement  to explain  why the criteria  are not, or may not be, met; and 
(b) complete,  unredacted  copies  of the source  material  used in the assessment  of the precision 
bred organism  for each criterion  that has not been  met, which  may include  but is not 
limited  to test results,  scientific  analyses,  data,  studies,  surveys  or scientific  records. 
28 Regulation  45 SCHEDULE  5 
Consequential  Amendments 
1. [Placeholder  for consequential  amendments] 
29 EXPLANA TORY NOTE 
(This  note is not part of the Regulations) 
These  Regulations  make  provision  for systems  to regulate  the release  for research  purposes,  and 
marketing  of, precision  bred plants.  They  also provide  for risk assessments  for precision  bred 
plants  imported  or acquired  for contained  use and provide  for an authorisation  process  for food 
and feed produced  from  precision  bred plants. 
Regulation  3 and Schedule  1 set out the notification  requirements  for the release  of precision 
bred plants  and the content  of release  notices. 
Regulation  4 provides  for the transitional  arrangements  in relation  to regulation  3 in respect  of 
qualifying  higher  plants  notified  under  the Genetically  Modified  Organism  (Deliberate  Release) 
(Amendment)(England  Regulations  2022  which  must  be re-notified  under  these  Regulations  within 
3 months  of these  Regulations  coming  into force. 
Regulation  5 and Schedule  2 provide  for the content  of marketing  notices  and the process  and 
procedure  for application  to the Secretary  of State  for precision  bred confirmation  of a precision 
bred plant.  Schedule  3 provides  for the content  of the general  description  of a precision  bred 
plant. 
Regulation  6 extends  the reporting  period  in relation  to the provision  of further  information  to 
the advisory  committee  advising  on a precision  bred confirmation  and provides  for a marketing 
notice  to be treated  as withdrawn  if further  information  is not provided  within  60 days. 
Regulation  7 sets out the circumstances  and process  for revocation  of a precision  bred confirmation. 
Regulations  8 and 9 provide  for the review  and appeal  of a decision  to issue  a precision  bred 
confirmation  and a decision  to revoke  a precision  bred confirmation. 
Regulation  10 sets out the information  to be included  in the Precision  Breeding  Register  and 
regulation  11 provides  for the keeping  of the Register . 
Regulation  12 sets out the risk assessment  requirements  for precision  bred plants  imported  and 
acquired  for contained  use. 
Part 6 provides  for the monitoring  and inspection  of the release  and marketing  of precision  bred 
organisms  including  the functions  of inspectors  and powers  of inspections  and entry . 
Regulations  18 to 21 and Schedule  4 set out the process  for applying  for marketing  authorisations 
for food and feed produced  from  precision  bred plants  and the required  information  for inclusion 
in a food and feed marketing  authorisation  notice.  Regulation  19 includes  the assignment  of 
functions  to the Food  Standards  Authority  in relation  to food and feed marketing  authorisations. 
Regulation  22 provides  for the risk assessment  of applications  for food and feed marketing 
authorisations  by the Food  Standards  Authority , including  obtaining  expert  advice  and the provision 
of reports  to the Secretary  of State. 
Regulation  23 sets out the requirements  for the consideration  of marketing  authorisation 
applications,  and the issuing  of marketing  authorisations,  by the Secretary  of State. 
Regulation  24 records  the duties  on the authorisation-holders  of marketing  authorisations. 
30 Regulation  25 sets out the circumstances  and process  for the variation  and revocation  of food 
and feed marketing  authorisations. 
Regulation  26 provides  a process  for the management  of commercially  confidential  information. 
Regulation  27 sets out the information  to be included  in the Food  and Feed  Register  and provides 
for the keeping  of the Register . 
Part 9 provides  for the monitoring  and inspection  of food and feed marketing  authorisations 
including  setting  out the designated  enforcement  authorities,  the appointment  and functions  of 
inspectors  and powers  of inspection  and entry . 
Part 10 provides  for the enforcement  of these  Regulations  by way of civil sanctions  in respect 
of relevant  breaches  in regulation  34 (including  the issue  of various  notices).  Regulations  35 and 
36 provide  for enforcement  notices  and the content  of enforcement  notices  including  authority  to 
withdraw  or amend  any notice.  Regulations  37 and 38 provide  for compliance  notices  and stop 
notices  while  Regulation  39 enables  the Secretary  of State  and inspectors  to issue  monetary 
penalty  notices.  Regulation  40 provides  for the review  of an enforcement  notice  by the Secretary 
of State  while  regulation  41 provides  a right  of appeal  to the First-tier  Tribunal.  All notices, 
except  stop notices  may be suspended  pending  the determination  of an appeal.  The First-tier 
Tribunal  may on appeal  withdraw , confirm  or vary any requirement  of a notice  or remit  the 
decision  to the Secretary  of State.  Regulation  42 provides  for the recovery  of costs  associated 
with enforcement  while  regulation  43 sets out the provisions  for the review  and appeal  of costs 
notices. 
Regulation  44 makes  general  provision  in relation  to notices  and regulation  45 and Schedule  5 
set out the consequential  amendments. 
An impact  assessment  [ ] 
31