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132W PDFTitle:FOOD AND DRUGS (COMPOSITION AND LABELLING) REGULATIONSGazette Number:L.N. 69 of 2008
Schedule:6Heading:ITEMS EXEMPT FROM PART 1 OF SCHEDULE 5Version Date:01/07/2010

[regulation 4B]

PART 1

ITEMS EXEMPT FROM PART 1 OF SCHEDULE 5 UNDER
REGULATION 4B(2)(a) OF THESE REGULATIONS

1. Prepackaged food with an alcoholic strength by volume of more than 1.2% as determined in the manner described in the definition of "alcoholic strength" in section 53 of the Dutiable Commodities Ordinance (Cap 109).

2. Prepackaged food sold at a catering establishment which is usually bought for immediate consumption.

3. Individually wrapped confectionery products in a fancy form intended for sale as single items.

4. Individually wrapped preserved fruits which are not enclosed in any further packaging and which are intended for sale as single items.

5. Prepackaged food packed in a container which has a total surface area of less than 100 cm2.

6. Fruit or vegetable, whether fresh, chilled, frozen or dried-
        (a) packed in a container which contains no other ingredient; and
        (b) to which no other ingredient has been added.

7. Carbonated water-
        (a) to which no ingredient other than carbon dioxide has been added; and
        (b) the marking or label of which indicates that it has been carbonated.

8. Spring water and mineral water (including water to which minerals have been artificially added and which is described as mineral water).

9. Prepackaged food which does not have any energy value or contain any content of any nutrient referred to in section 1(1)(b) of Schedule 5.

10. Meat, marine or fresh water fish or any other form of aquatic life commonly used for human consumption-
        (a) which is in a raw state;
        (b) packed in a container which contains no other ingredient; and
        (c) to which no other ingredient has been added.

11. Prepackaged food containing assorted ingredients which is-
        (a) prepared and sold to an ultimate consumer at the same premises;
        (b) not intended for sale for immediate consumption; and
        (c) intended to be subjected to a process of cooking for the purpose of rendering it fit for human consumption.

12. Soup pack containing assorted ingredients-
        (a) which has not been subjected to any process of heating in the course of manufacture;
        (b) which is not intended for sale for immediate consumption; and
        (c) which is intended to be subjected to a process of cooking for the purpose of rendering it fit for human consumption in the form of soup.

13. Prepackaged food sold-
        (a) by a charitable institution or trust of a public character which is exempt from tax under section 88 of the Inland Revenue Ordinance (Cap 112); and
        (b) in an event held for charitable purposes.

14. Prepackaged food-
        (a) processed and sold to an ultimate consumer at the same premises; or
        (b) processed at a place which is adjacent to, or in the immediate vicinity of, the premises where the food is sold to an ultimate consumer,
and not offered for sale outside the premises referred to in paragraph (a) or (b).

15. Prepackaged food sold to a catering establishment as a single item.

Note: In this Part-
      "prepared" (製備) includes boning, paring, grinding, cutting, cleaning, trimming, flavouring or packaging, but does not include processing;
      "processed" (加工處理) includes any treatment or process resulting in a substantial change in the natural state of any food, and "processing" (加工處理) in the definition of "prepared" in this Note shall be construed accordingly.

PART 2

PREPACKAGED FOOD WITH ANNUAL SALES
VOLUME NOT EXCEEDING 30000 UNITS
MAY BE EXEMPT FROM PART 1 OF
SCHEDULE 5 UNDER REGULATION
4B(2)(b) OF THESE REGULATIONS

1. Exemption from Part 1 of Schedule 5

(1) Upon an application made under subsection (2), the Authority may, subject to section 3(1), grant an exemption in respect of any prepackaged food from the requirements of Part 1 of Schedule 5 if the Authority is satisfied that the annual sales volume of food of the same version in Hong Kong would not exceed 30000 units.
(2) Any importer or manufacturer of a prepackaged food may apply to the Authority for exemption under subsection (1) in such manner as the Authority may determine.
(3) An applicant for exemption shall pay to the Authority $345 upon approval of the application.
(4) The Authority may-
        (a) impose such conditions as the Authority may deem fit; and
        (b) require the applicant to give an undertaking to comply with such conditions as the Authority may from time to time impose with regard to the prepackaged food to which the exemption applies.
(5) An exemption granted under subsection (1) shall be valid-
        (a) (where no other exemption granted under that subsection is for the time being in force in relation to the version of the prepackaged food concerned) for one year;
        (b) (where only one other exemption granted under that subsection is for the time being in force in relation to the version of the prepackaged food concerned) until the expiry date of that other exemption; or
        (c) (where 2 or more other exemptions granted under that subsection are for the time being in force in relation to the version of the prepackaged food concerned) until the expiry date of the first of such exemptions.

2. Renewal of exemption

(1) Upon an application made under subsection (2), the Authority may, subject to section 3(2), renew an exemption granted under section 1(1) if the Authority is satisfied that-
        (a) (where no other exemption granted under section 1(1) is for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of the exemption would not exceed 30000 units;
        (b) (where only one other exemption granted under section 1(1) is for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of that other exemption would not exceed 30000 units; or
        (c) (where 2 or more other exemptions granted under section 1(1) are for the time being in force in relation to the version of the prepackaged food concerned) the total sales volume of the version of the prepackaged food in Hong Kong within the validity period of the first of such exemptions would not exceed 30000 units.
(2) A person to whom an exemption has been granted may, before the expiration of the exemption, apply to the Authority for renewal of the exemption in such manner as the Authority may determine.
(3) An applicant for renewal shall pay to the Authority $335 upon approval of the application.
(4) A renewal under subsection (1) takes effect-
        (a) on the day following the expiration of the exemption; and
        (b) for a period of one year or such lesser period as may be specified by the Authority.

3. Refusal to grant, refusal to renew or revocation
of exemption

(1) The Authority may refuse to grant an exemption under section 1(1) if-
        (a) the applicant has, in relation to the prepackaged food to which the application relates, failed to comply with any condition imposed under section 1(4) within the past 2 years; or
        (b) the annual sales volume of the version of the prepackaged food to which the application relates in Hong Kong exceeded 30000 units in any one of the past 2 years.
(2) The Authority may refuse to renew an exemption under section 2(1) if the applicant has, in relation to the prepackaged food to which the application relates, failed to comply with any condition imposed under section 1(4) within the past 2 years.
(3) The Authority may revoke an exemption granted under section 1(1) or renewed under section 2(1) ("the exemption") if-
        (a) the importer or manufacturer to whom the exemption has been granted ("the grantee") has failed to comply with any condition imposed under section 1(4); or
        (b) the total sales volume of the version of the prepackaged food to which the exemption applies in Hong Kong within the validity period of the exemption exceeds 30000 units.
(4) The Authority shall not revoke an exemption unless the Authority-
        (a) notifies the grantee in writing of-
        (i) his intention to revoke the exemption; and
        (ii) the grounds upon which the Authority proposes to revoke the exemption;
        (b) permits the grantee to make representations to the Authority in writing within the period specified in the notice; and
        (c) considers the representations, if any, made by the grantee.
(5) If the Authority revokes an exemption, the Authority shall, as soon as practicable, notify the grantee in writing and specify in the notice-
        (a) the grounds for the revocation; and
        (b) the date on which the revocation is to take effect.
(6) A revocation takes effect on the expiry of 30 days from the date on which the decision to revoke the exemption is made.
(Schedule 6 added L.N. 69 of 2008)