Meaning of “pre-market approval”
Open ↗105. In this Part, “pre‑market approval” means an approval granted under this Part for a novel food or a genetically modified food to be available for consumption as food by the general public, after the Agency makes an assessment of the public health and safety considerations having regard to —(a)
the potential for adverse effects in humans;
(b)
the composition or structure of the novel food or genetically modified food;
(c)
the process by which the novel food or genetically modified food has been prepared;
(d)
the source from which the novel food or genetically modified food is derived;
(e)
the likely patterns and levels of consumption of the novel food or genetically modified food; and
(f)
any other relevant matters.
Supplying defined food
Open ↗106.—(1) A person commits an offence if —(a)
the person supplies any food in Singapore;
(b)
the food is a defined food; and
(c)
the person knows, or ought reasonably to know, that the food is a defined food.
(2) A person who is guilty of an offence under subsection (1) shall be liable on conviction —(a)
where the person is an individual —(i)
to a fine not exceeding $15,000 or to imprisonment for a term not exceeding 6 months or to both; or
(ii)
where the individual is a repeat offender — to a fine not exceeding $30,000 or to imprisonment for a term not exceeding 12 months or to both; or
(b)
where the person is not an individual —(i)
to a fine not exceeding $30,000; or
(ii)
where the person is a repeat offender — to a fine not exceeding $60,000.
(3) In subsection (2), “repeat offender”, in relation to an offence under subsection (1), means a person who —(a)
is convicted, or found guilty, of such an offence (called the current offence); and
(b)
has been convicted or found guilty, on at least one other earlier occasion within the period of 5 years immediately before the date on which the person is convicted or found guilty of the current offence, of an offence under subsection (1).
(4) For the purposes of this section, it is immaterial whether the food concerned is safe.
Supplying defined food — strict liability
Open ↗107.—(1) A person commits an offence if —(a)
the person supplies any food in Singapore; and
(b)
the food is a defined food.
(2) Strict liability applies to the offence in subsection (1).
(3) A person who is guilty of an offence under subsection (1) shall be liable on conviction —(a)
where the person is an individual — to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 3 months or to both; or
(b)
where the person is not an individual — to a fine not exceeding $10,000.
(4) For the purposes of this section, it is immaterial whether the food concerned is safe.
Defence of due diligence
Open ↗108.—(1) In a prosecution of a person for an offence under section 106 or 107, it is a defence for the person charged to prove, on a balance of probabilities, that —(a)
the commission of the offence was due to —(i)
an act or omission of another person; or
(ii)
an accident or some other cause outside the control of the person charged; and
(b)
the person charged took all reasonable precautions and exercised all due diligence to prevent the commission of the offence by the person, or by another person under the control of the person charged.
(2) In subsection (1)(a), another person does not include a person who was at the time of the commission of the offence —(a)
an employee or agent of the person charged; or
(b)
if the person charged is an entity, an officer of the entity.
(3) Section 26H(4) of the Penal Code 1871 does not apply in relation to a strict liability offence under this Part.
Application for pre-market approval
Open ↗109. Without limiting section 292(4), the Agency may refuse to consider an application for pre‑market approval with respect to a novel food or a genetically modified food if the application does not contain sufficient information for the Agency to make an assessment as to the public health and safety considerations as described in section 105.
Grant of pre-market approval
Open ↗110.—(1) Without limiting section 294, in granting a pre‑market approval in respect of a novel food or a genetically modified food, the Agency may impose any conditions that the Agency considers requisite or expedient to ensure that the novel food or genetically modified food, as the case may be —(a)
is what it says it is; and
(b)
is safe, and after having regard to the public health and safety considerations as described in section 105.
(2) The Agency may, at the request of an applicant for pre‑market approval in respect of a novel food or a genetically modified food, grant the pre‑market approval subject to an exclusive use condition.
Validity of pre-market approval
Open ↗111. A pre‑market approval granted in respect of a novel food or a genetically modified food has effect until —(a)
the approval is cancelled under section 112; or
(b)
in the case of a novel food, it earlier ceases to be a novel food.
Cancelling pre-market approval
Open ↗112. Subject to Division 4 of Part 14, the Agency may cancel (without any compensation) a pre‑market approval in respect of a novel food or a genetically modified food if the Agency is satisfied that —(a)
the pre‑market approval had been obtained by fraud or misrepresentation;
(b)
any condition of the pre‑market approval is contravened or not complied with;
(c)
after the grant of the pre‑market approval, there has been a material change to —(i)
the method by which the novel food or genetically modified food is manufactured, prepared, preserved, packaged or stored; or
(ii)
any other information relating to the novel food or genetically modified food which was provided in connection with the application for the pre-market approval; or
(d)
the public interest of Singapore requires the cancellation of the pre‑market approval.
Restrictions on transfer of pre-market approval
Open ↗113.—(1) Every pre‑market approval, and any rights, benefits or privileges under the pre‑market approval, are not transferable or assignable to any other person unless —(a)
the pre‑market approval contains a condition authorising the transfer or assignment; and
(b)
the Agency consents in writing to the transfer or assignment.
(2) Any consent under subsection (1) may be given subject to compliance with any conditions that the Agency thinks fit to impose, which may include conditions modifying, or requiring or otherwise providing for the making of modifications to, the conditions of the pre‑market approval.
(3) A transfer or an assignment, or a purported transfer or assignment, of a pre‑market approval, or of any rights, benefits or privileges under the pre‑market approval, is void and of no effect —(a)
if the pre‑market approval is not capable of transfer or assignment;
(b)
if the transfer or assignment, or purported transfer or assignment, is in breach of a condition of the pre‑market approval licence; or
(c)
if there has, before the transfer or assignment or purported transfer or assignment, been a contravention of a condition imposed under subsection (2).
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
