The Food Hygiene (Scotland) Regulations 2005

Regulation 2(1)

SCHEDULE 1 Definitions of Community legislation

• “Regulation 178/2002” means Regulation (EC) No. 178/2002 of the European Parliament and of the Council 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(1) as last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council amending Regulation (EC) No. 178/2002 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(2);

• “Regulation 852/2004” means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs(3);

• “Regulation 853/2004” means Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin(4) as read with Directive 2004/41;

• “Regulation 854/2004” means Regulation (EC) No. 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(5) as amended by Regulation (EC) No. 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(6) as read with Directive 2004/41; and

• “Directive 2004/41” means Directive 2004/41/EC of the European Parliament and of the Council repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC(7).

Regulations 2(1) and 17

SCHEDULE 2 Specified Community provisions

1. Provision of Community Regulations	2. Subject matter
Article 3 of Regulation 852/2004	Requirement that food business operators ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in Regulation 852/2004.
Article 4(1) of Regulation 852/2004	Requirement that food business operators carrying out primary production and specified associated operations comply with the general hygiene provisions laid down in Part A of Annex I to Regulation 852/2004 and any specific requirements provided for in Regulation 853/2004.
Article 4(2) of Regulation 852/2004	Requirement that food business operators carrying out any stage of production, processing and distribution of food after those stages to which Article 4(1) applies comply with the general hygiene requirements laid down in Annex II to Regulation 852/2004 and any specific requirements provided for in Regulation 853/2004.
Article 4(3) of Regulation 852/2004	Requirement that food business operators, as appropriate, adopt certain specific hygiene measures.
Article 5(1) of Regulation 852/2004	Requirement that food business operators (other than those excepted in Article 5(3)) put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
Article 5(2) of Regulation 852/2004	Requirement that when any modification is made in the product, process, or any step, food business operators review the procedure referred to in Article 5(1) and make the necessary changes to it.
Article 5(4)(a) of Regulation 852/2004	Requirement that food business operators provide the competent authority with evidence of their compliance with Article 5(1).
Article 5(4)(b) of Regulation 852/2004	Requirement that food business operators ensure that any documents describing the procedures developed in accordance with Article 5 are up to date.
Article 5(4)(c) of Regulation 852/2004	Requirement that food business operators retain documents and records for an appropriate period.
Article 6(1) of Regulation 852/2004	Requirement that food business operators co operate with the competent authorities in accordance with other applicable Community legislation or national law.
Article 6(2), first paragraph of Regulation 852/2004	Requirement that a food business operator notify the competent authority of each establishment under its control that carries out any of the stages of production, processing and distribution of food.
Article 6(2), second paragraph of Regulation 852/2004	Requirement that food business operators ensure that the competent authority has up to date information on establishments.
Article 6(3) of Regulation 852/2004	Requirement that food business operators ensure that establishments are approved by the competent authority when approval is required.
Article 3(1) of Regulation 853/2004	Requirement that food business operators comply with the relevant provisions of Annexes II and III to Regulation 853/2004.
Article 3(2) of Regulation 853/2004	Requirement that food business operators do not use any substance other than potable water or, when Regulation 852/2004 or Regulation 853/2004 permits its use, clean water, to remove surface contamination from products of animal origin unless use of the substance has been approved and any conditions for its use complied with.
Article 4(1) of Regulation 853/2004	Requirement that food business operators place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments– (a) that meet the relevant requirements of Regulation 852/2004, those of Annexes II and III of Regulation 853/2004 and other relevant requirements of food law; and (b) that the competent authority has registered or, where required in accordance with Article 4(2), approved.
Article 4(2) of Regulation 853/2004	Requirement that establishments handling those products of animal origin for which Annex III to Regulation 853/2004 lays down requirements do not operate unless the competent authority has approved them in accordance with Article 4(3).
Article 4(3) of Regulation 853/2004	Requirement that establishments subject to approval in accordance with Article 4(2) do not operate unless the competent authority has, in accordance with Regulation 854/2004– (a) granted the establishment approval to operate following an on–site visit; or (b) provided the establishment with conditional approval.
Article 4(4) of Regulation 853/2004	Requirement that food business operators co operate with the competent authorities in accordance with Regulation 854/2004 including ensuring that an establishment ceases to operate if it is no longer approved.
Article 5(1) of Regulation 853/2004	Requirement that food business operators do not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has– (a) a health mark applied in accordance with Regulation 854/2004; or (b) when Regulation 854/2004 does not provide for the application of a health mark, an identification mark applied in accordance with Section I of Annex II to Regulation 853/2004.
Article 5(2) of Regulation 853/2004	Requirement that food business operators apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with Regulation 853/2004 in establishments meeting the requirements of Article 4.
Article 5(3) of Regulation 853/2004	Requirement that food business operators do not remove a health mark applied in accordance with Regulation 854/2004 from meat unless they cut or process it or work upon it in another manner.
Article 6(1) and (2) of Regulation 853/2004	Requirement that food business operators ensure that importation of products of animal origin only takes place where certain conditions are met.
Article 6(3) of Regulation 853/2004	Requirement that food business operators importing products of animal origin shall ensure that– (a) products are made available for control upon importation in accordance with Council Directive 97/78/EC(8); (b) importation complies with the requirements of Council Directive 2002/99/EC(9); and (c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III to Regulation 853/2004.
Article 6(4) of Regulation 853/2004	Requirement that food business operators importing food containing both products of plant origin and processed products of animal origin ensure that the processed products of animal origin satisfy the requirements of paragraphs (1) to (3) of Article 6.
Article 7 of Regulation 853/2004	Requirement that food business operators ensure that certificates or other documents accompany consignments of products of animal origin when required in accordance with Annex II or III to Regulation 853/2004.
Article 8 of Regulation 853/2004	Requirement that food business operators intending to place specified foods of animal origin on the market in Sweden or Finland comply with the rules set out in Article 8(2).

Regulation 29

SCHEDULE 3 Bulk transport in sea-going vessels of liquid oils or fats or of raw sugar

Offence

1.  Any person who contravenes or fails to comply with any of the requirements of this Schedule is guilty of an offence.

Liquid oils or fats

2.—(1) The bulk transport in sea-going vessels of liquid oils or fats which are to be processed, and which are intended for or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions–

(a) where the oil or fat is transported in a stainless steel tank, or tank lined with epoxy resin or technical equivalent, the immediately previous cargo transported in the tank shall have been a foodstuff or a cargo from the list of acceptable previous cargoes for liquid oils or fats; and

(b) where the oil or fat is transported in a tank of materials other than those specified in sub paragraph (a), the three previous cargoes transported in the tanks shall have been foodstuffs or from the list of acceptable previous cargoes for liquid oils or fats.

(2) For the purposes of this paragraph “list of acceptable previous cargoes for liquid oils or fats” means the list set out in the Annex to Commission Directive 96/3/EC.

3.  The bulk transport in sea-going vessels of liquid oils or fats which are not to be further processed, and which are intended for or are likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions–

(a) the tank shall be of stainless steel or lined with epoxy resin or technical equivalent; and

(b) the three previous cargoes transported in the tank shall have been foodstuffs.

4.  The captain of a sea-going vessel transporting, in tanks, bulk liquid oils or fats intended for or likely to be used for human consumption shall keep accurate documentary evidence relating to the three previous cargoes carried in the tanks concerned, and the effectiveness of the cleaning process applied between those cargoes.

5.  Where the cargo has been trans-shipped, in addition to the documentary evidence required by virtue of paragraph 4, the captain of the receiving vessel shall keep accurate documentary evidence that the transport of the bulk liquid oil or fat complied with the provisions of paragraph 2 or 3 during previous shipment and of the effectiveness of the cleaning process used between those previous cargoes on the vessel from which the bulk liquid oil or fat was trans-shipped.

6.  Upon request, the captain of the vessel shall provide the enforcement authority with the documentary evidence described in paragraphs 4 and 5.

Raw sugar

7.  The bulk transport by sea of raw sugar which is not intended for use as food or as a food ingredient without a full and effective refining process is permitted in receptacles, containers or tankers that are not exclusively used for the transport of foodstuffs.

8.  The receptacles, containers or tankers referred to in paragraph 7 shall be subject to the following conditions–

(a) prior to loading the raw sugar, the receptacle, container or tanker shall be effectively cleaned to remove residues of the previous cargo and other soiling and inspected to establish that such residues have been removed effectively; and

(b) the immediate previous cargo prior to the raw sugar shall not have been a bulk liquid.

9.  A food business operator who is responsible for the transport of raw sugar by sea under paragraph 7 shall keep documentary evidence, accurately describing in detail the immediate previous cargo carried in the receptacle, container or tanker concerned, and the type and effectiveness of the cleaning process applied prior to the transport of the raw sugar.

10.  The documentary evidence shall accompany the consignment of raw sugar during all stages of transport to the refinery and a copy shall be retained by the refinery. The documentary evidence shall be marked as follows in a clearly visible and indelible fashion, in one or more Community languages: “This product must be refined before being used for human consumption”.

11.  On request, a food business operator responsible for the transport of the raw sugar or the refining process shall provide the enforcement authority with the documentary evidence referred to in paragraphs 9 and 10.

12.  Raw sugar which has been transported by sea in receptacles, containers or tankers which are not exclusively reserved for the transport of foodstuffs shall be subjected to a full and effective refining process before being considered suitable for use as food or as a food ingredient.

13.  In fulfilling the obligations under Article 5(1) of Regulation 852/2004 (hazard analysis and critical control points) in relation to the bulk transport of raw sugar by sea under paragraph 7, a food business operator who is responsible for the transport or refining of raw sugar shall–

(a) consider the cleaning process undertaken prior to the loading of the sugar for transport by sea to be a critical control point as referred to in Article 5(2)(b) of Regulation 852/2004; and

(b) take into account the nature of the previous cargo which has been transported in any receptacle, container or tanker used for the transport of the sugar.

Interpretation

14.—(1) For the purposes of this Schedule any words or expressions used both in this Schedule and in Commission Directive 96/3/EC or Commission Directive 98/28/EC granting a derogation from certain provisions of Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport by sea of bulk raw sugar(10) shall bear the same meanings as they respectively have in those Directives.

(2) In this Schedule “Commission Directive 96/3/EC” means Commission Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(11) as amended by Commission Directive 2004/4/EC amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(12).

Regulation 30

SCHEDULE 4 Temperature control requirements

Scope

1.—(1) Subject to sub paragraph (2), this Schedule applies in relation to any person to whose food business operations Regulation 852/2004 applies but Regulation 853/2004 does not apply.

(2) This Schedule does not apply to food business operations on any ship or aircraft.

Chill and hot holding requirements

2.—(1) Subject to sub paragraph (2), any person who keeps food with respect to which any commercial operation is being carried out at or in food premises otherwise than–

(a) in a refrigerator or refrigerating chamber or in a cool ventilated place; or

(b) at a temperature above 63°C,

is guilty of an offence.

(2) Sub paragraph (1) shall not apply to any food–

(a) which is undergoing preparation for sale;

(b) which is exposed for sale or has been sold to a consumer whether for immediate consumption or otherwise;

(c) which, immediately following any process of cooking to which it is subjected or the final processing stage if no cooking process is applied, is being cooled under hygienic conditions as quickly as possible to a temperature which would not result in a risk to health;

(d) which, in order that it may be conveniently available for sale on the premises to consumers, it is reasonable to keep otherwise than as referred to in sub paragraph (1);

(e) which, for the duration of its shelf life, may be kept at ambient temperatures with no risk to health;

(f) to which Council Regulation (EEC) No. 1906/90 on certain marketing standards for poultry(13), as last amended by Council Regulation (EC) No. 1101/98(14), applies; or

(g) to which Council Regulation (EEC) No. 1907/90 on certain marketing standards for eggs(15), as last amended by Council Regulation (EC) No. 2052/2003(16), applies.

Reheating of food

3.—(1) Food which in the course of a commercial operation has been heated and which is thereafter reheated before being served for immediate consumption or exposed for sale shall, on being reheated, be raised to a temperature of not less than 82°C.

(2) Any person who contravenes the provisions of sub paragraph (1) is guilty of an offence.

(3) In any proceedings for an offence under sub paragraph (2), it shall be a defence for the accused to prove that the food could not have been raised to a temperature of not less than 82°C without a deterioration of its qualities.

Interpretation

4.  In this Schedule–

“shelf life” means–

(a)

in relation to food with respect to which an indication of minimum durability is required in accordance with regulation 20 of the Food Labelling Regulations 1996(17) (form of indication of minimum durability), the period up to and including the date required to be included in that indication;

(b)

in relation to food with respect to which a “use by” date is assigned in the form required in accordance with regulation 21 of the Food Labelling Regulations 1996 (form of indication of “use by” date), the period up to and including that date; and

(c)

in relation to food which is not required to bear an indication of minimum durability or a “use by” date, the period for which the food can be expected to remain fit for sale if it is kept in a manner which is consistent with food safety.

Regulation 31

SCHEDULE 5 Direct supply by the producer of small quantities of meat from poultry and lagomorphs slaughtered on the farm

Scope

1.  This Schedule applies to the direct supply by the producer of small quantities of meat from poultry or lagomorphs that have been slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat.

Offence

2.  Any person who contravenes or fails to comply with any of the provisions of this Schedule is guilty of an offence.

Requirements

3.  No person shall sell meat from poultry or lagomorphs unless it bears a label or other marking clearly indicating the name and address of the farm where it was slaughtered.

4.  The producer shall–

(a) keep a record in adequate form to show the number of birds and the number of lagomorphs received into, and the amounts of fresh meat despatched from, the producer’s premises during each week;

(b) retain the record for a period of 1 year; and

(c) make the record available to an authorised officer on request.

Regulation 32

SCHEDULE 6 Restrictions on the placing on the market of raw milk and raw cream intended for direct human consumption

1.  No person shall place on the market raw milk, or raw cream, intended for direct human consumption.

2.  Any person who contravenes paragraph 1 is guilty of an offence.

3.  In any proceedings for an offence in respect of a contravention of paragraph 1, it shall be a defence for the accused to prove that the raw milk or raw cream in respect of which the offence is alleged to have been committed was intended for export–

(a) to England and that the milk or cream complies with the provisions of the Food Hygiene (England) Regulations 2005(18);

(b) to Wales and that the milk or cream complies with Regulation 853/2004 and any national rules applicable in relation to Wales made by the National Assembly for Wales pursuant to Article 10.8(a) of Regulation 853/2004;

(c) to Northern Ireland and that the milk or cream complies with the provisions of the Food Hygiene Regulations (Northern Ireland) 2005(19);

(d) to a member State other than the United Kingdom and that the milk or cream complies with Regulation 853/2004 and any national rules applicable in relation to that member State made pursuant to Article 10.8(a) of Regulation 853/2004; or

(e) to a third country in accordance with Article 12 of Regulation 178/2002 as read with Article 11 of Regulation 852/2004.

Regulation 34

SCHEDULE 7 Revocations

Column 1	Column 2	Column 3
Instruments	Reference	Extent of revocation
The Ice-Cream (Scotland) Regulations 1948	S.I. 1948/960	The whole Regulations
The Ungraded Eggs (Hygiene) (Scotland) Regulations 1990	S.I. 1990/1336	The whole Regulations
The Food Premises (Registration) Regulations 1991	S.I. 1991/2825	The whole Regulations
The Meat Hygiene Appeals Tribunal (Procedure) Regulations 1992	S.I. 1992/2921	The whole Regulations
The Egg Products Regulations 1993	S.I. 1993/1520	The whole Regulations
The Meat Products (Hygiene) Regulations 1994	S.I. 1994/3082	The whole Regulations
The Fresh Meat (Hygiene and Inspection) Regulations 1995	S.I. 1995/539	The whole Regulations
The Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995	S.I. 1995/540	The whole Regulations
The Dairy Products (Hygiene) (Scotland) Regulations 1995	S.I. 1995/1372	The whole Regulations
The Food Safety (General Food Hygiene) Regulations 1995	S.I. 1995/1763	The whole Regulations
The Wild Game Meat (Hygiene and Inspection) Regulations 1995	S.I. 1995/2148	The whole Regulations
The Food Safety (Temperature Control) Regulations 1995	S.I. 1995/2200	The whole Regulations
The Minced Meat and Meat Preparations (Hygiene) Regulations 1995	S.I. 1995/3205	The whole Regulations
The Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998	S.I. 1998/994	The whole Regulations
The Gelatine (Intra-Community Trade) (Scotland) Regulations 2001	S.S.I. 2001/169	The whole Regulations
The Food Safety (Ships and Aircraft) (England and Scotland) Order 2003	S.I. 2003/1895	In article 2(1) paragraph (b) of the definition of “the principal Hygiene and Temperature Control provisions” Paragraph 2(b) of the Schedule
The Collagen and Gelatine (Intra-Community Trade) (Scotland) (No. 2) Regulations 2003	S.S.I. 2003/568	The whole Regulations
The Egg (Marketing Standards) (Enforcement) (Scotland) Regulations 2005	S.S.I. 2005/332	In regulation 2– (a) the definition of “the Agency”; (b) the definition of “Council Decision 94/371/EC”; (c) (i) paragraph (b) of the definition of “specified Community provision”; and (ii) “and” where it appears at the end of paragraph (a) of that definition. Regulations 3 and 4(2).

(1)

O.J. No. L 31, 1.2.02, p.1.

(2)

O.J. No. L 245, 29.9.03, p.4.

(3)

O.J. No. L 139, 30.4.04, p.1. The revised text of Regulation 852/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.3).

(4)

O.J. No. L 139, 30.4.04, p.55. The revised text of Regulation 853/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.22).

(5)

O.J. No. L 139, 30.4.04, p.206. The revised text of Regulation 854/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.83).

(6)

O.J. No. L 165, 30.4.04, p.1. The revised text of Regulation 882/2004 is now set out in a Corrigendum (O.J. No. L 191, 28.5.04, p.1).

(7)

O.J. No. L 157, 30.4.04, p.33. The revised text of Directive 2004/41/EC is now set out in a Corrigendum (O.J. No. L 195, 2.6.04, p.12).

(8)

O.J. No. L 24, 30.1.98, p.9.

(9)

O.J. No. L 18, 23.1.03, p.11.

(10)

O.J. No. L 140, 12.5.98, p.10.

(11)

O.J. No. L 21, 27.1.96, p.42.

(12)

O.J. No. L 15, 22.1.04, p.25.

(13)

O.J. No. L 173, 6.7.90, p.1

(14)

O.J. No. L 157, 30.5.98, p.12.

(15)

O.J. No. L 173, 6.7.90, p.5.

(16)

O.J. No. L 305, 22.11.03, p.1.

(17)

S.I. 1996/1499, to which there are amendments not relevant to these Regulations.

(18)

S.I. 2005/2059.

(19)

S.R. (N.I.) 2005 No. 356.