PART 5Miscellaneous
Responsibilities of processorsI429
The owner of an establishment of initial processing of animal products must, in respect of each animal or animal product brought into that establishment, ensure that—
a
it does not contain—
i
a residue level which exceeds the maximum permitted limit;
ii
any unauthorised substance or product; and
b
any appropriate withdrawal period has been observed.
Unavailability of defenceI230
It is hereby declared that a person is not entitled to rely on the defence provided by section 21(1), (5) and (6) of the Act, as applied by regulation 32, in any proceedings alleging a contravention of regulation 8 or 10 if that person has contravened regulation 29.
Keeping and retention of recordsI531
1
The owner of an establishment of initial processing of animal products must keep such records as are sufficient, either alone or in combination with records or information held by some other person, to enable the animals from which those animal products were derived, and the farm of origin or departure of those animals, to be identified.
2
Persons holding a manufacturing or wholesale dealer’s authorisation granted under the Veterinary Medicines Regulations 2013, for purposes relating to a marketing authorisation for a product to which regulation 4 applies, must, in relation to hormonal substances and beta-agonists, keep a record in chronological order of—
a
quantities produced;
b
quantities purchased or otherwise acquired and from whom each quantity was purchased or acquired;
c
quantities sold and to whom each quantity was sold; and
d
quantities used in the production of pharmaceutical or veterinary medicinal products.
3
Any person required to keep a record by paragraph (1) or (2) must keep that record in a permanent and legible form and must retain that record for a period of three years from the end of the calendar year to which such record relates save in the case of a prescription intended to show that withdrawal periods have been observed, which must be retained for a period of five years from the date of the commencement of the withdrawal period to which it relates.
4
Subject to paragraph (5) if an authorised officer directs a person to produce for inspection a record which paragraph (1) or (2) requires that person to keep, the person must comply with the direction.
5
No direction may be given under paragraph (4) after the end of the period mentioned in paragraph (3).
6
The requirement in paragraph (3) to keep records in a legible form is not to be taken to prevent their being kept by means of computer.
7
Where a record is so kept, the duty under paragraph (4) to produce it for inspection, is a duty to produce it in a form in which it can be taken away.
Application and modification of provisions of the Food Safety Act 1990I132
1
The following provisions of the Act apply for the purposes of these Regulations and, unless the context otherwise requires, any reference in them to that Act is construed for the purposes of these Regulations as a reference to these Regulations—
a
section 2 (extended meaning of “sale” etc.);
b
section 3 (presumption that food is intended for human consumption);
c
section 20 (offences due to fault of another person);
d
section 21(1), (5) and (6) (defence of due diligence);
e
section 22 (defence of publication in the course of business);
f
section 33 (obstruction etc. of officers);
g
section 35(1) to (3) (punishment of offences) in so far as it relates to offences under section 33(1) and (2); and
h
section 36 (offences by bodies corporate).
2
Section 9 of the Act (inspection and seizure of suspected food) applies, subject to paragraph (3), for the purposes of these Regulations as if an animal product which it is an offence to sell under these Regulations were food which failed to comply with food safety requirements.
3
Section 9 of the Act applies with the following modifications—
a
for the words “food authority” in each place where they occur there are substituted the words “enforcement authority”; and
b
the reference in sub-section (5)(a) to section 7 of the Act is construed as a reference to these Regulations.
4
Section 29 of the Act (procurement of samples) applies subject to the modification that for the words “section 32 below” in sub-section (b)(ii) there is substituted the words “section 32 of the Act as applied by this regulation”.
5
Section 30 of the Act (analysis etc. of samples) applies subject to the modification that after the words “section 29 above” there is inserted the words, “, other than an official sample,”.
6
Section 32 of the Act (powers of entry) applies with the omission of the word “food” in sub-section (5) and the references to “regulations” in sub-section (1) are, for the purposes of these Regulations, construed as including a reference to Articles 14(6) and 16 of Regulation 470/2009.
7
Section 44 of the Act (protection of officers acting in good faith) applies subject to the modification that for the words “food authority” in each place where they occur there is substituted the words “enforcement authority”.
RevocationsI333
The instruments specified in the first column of the Schedule are revoked to the extent specified in the third column of the Schedule.
ReviewI634
1
This regulation does not apply in respect of the application of these Regulations in Scotland.
2
The Secretary of State must from time to time—
a
carry out a review of these Regulations;
b
set out the conclusions of the review in a report; and
c
publish the report.
3
In carrying out the review the Secretary of State must, so far as is reasonable, have regards to how Council Directive 96/22 and Council Directive 96/23 (which are implemented by these Regulations) are implemented in other member States.
4
The report must in particular—
a
set out the objectives intended to be achieved by these Regulations;
b
assess the extent to which the objectives have been achieved;
c
assess whether the objectives remain appropriate and, if so, the extent to which they could be achieved in a less burdensome way.
5
The first report under this regulation must be published before the end of the period of five years beginning with 6th May 2013.
6
Reports under this regulation are afterwards to be published at intervals not exceeding five years.