# The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013

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S

Scottish Statutory Instruments

# 2013 No. 266

Food

# The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013

Made

11th September 2013

Laid before the Scottish Parliament

13th September 2013

Coming into force

31st October 2013

The Scottish Ministers make the following Regulations in exercise of the powers conferred by sections 6(4), 16(1)(a), (c),                           (e) and (f), 17(1) and (2), 26(1) and (3), and 48(1) of the Food Safety Act 1990 F1, paragraph 1A of Schedule 2 to the European Communities Act 1972 F2 and all other powers enabling them to do so.                        

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears                           to the Scottish Ministers that it is expedient for any reference to an Article of or an Annex to any of the EU instruments specified in regulation 2(4) to be construed as a reference to that Article or that Annex as amended from time                           to time.                        

In accordance with section 48(4A) of the Food Safety Act 1990 F3, the Scottish Ministers have had regard to relevant advice given by the Food Standards Agency.                        

There has been consultation as required by Article 9 of 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 F4.                        

F11990 c.16. Section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990. Sections 16(1), 17(1) and (2) and 48(1) were amended by Schedule 5 to the Food Standards Act 1999 (c.28) (“the 1999 Act”). Section 48 was also amended by S.I. 2004/2990. Section 26(3) was amended by Schedule 6 to the 1999 Act. Section 53(2) was amended by paragraph 19 of Schedule 16 to the                              Deregulation and Contracting Out Act 1994 (c.40), **Schedule 6** to the 1999 Act, S.I. 2004/2990 and S.I. 2004/3279. By virtue of section 40(2) of the 1999 Act, amendments made by Schedule 5 to that Act are to be taken as pre-commencement                              enactments for the purposes of the Scotland Act 1998 (c.46) (“the 1998 Act”). The functions of the Secretary of State, in so far as within devolved competence, were transferred to the Scottish Ministers                              by virtue of section 53 of the 1998 Act. In so far as not transferred, and in so far as relating to food (including drink)                              including the primary production of food, relevant functions were transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2005 (S.I. 2005/849).

F21972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51) and amended by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7).

F3Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the 1999 Act.

F4OJ L 31, 1.2.2002, p.1. That Regulation was last amended by Commission Regulation (EC) No 596/2009 of the European Parliament                              and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the treaty to Council                              Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny                              – Part Four (OJ L 188, 18.7.2009, p.14).

## **PART 1**SIntroductory

### Citation, extent and commencementS

1.  These Regulations may be cited as the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations                     2013, extend to Scotland only and come into force on 31st October 2013.                  

### InterpretationS

2.—(1) In these Regulations—                  

“the Act” means the Food Safety Act 1990;                  

“Directive 2009/32” means Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents                     used in the production of foodstuffs and food ingredients F5;                  

“Regulation 2065/2003” means Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods F6;                  

“Regulation 1332/2008” means Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes F7;                  

“Regulation 1333/2008” means Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives F8, as read with—                  

Commission Regulation (EU) No 1129/2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives F9;                           

Commission Regulation (EU) No 1130/2011 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food additives for use in                              food additives, food enzymes, food flavourings and nutrients F10; and                           

Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation                              (EC) No 1333/2008 of the European Parliament and of the Council F11;                           

“Regulation 1334/2008” means Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for                     use in and on foods F12, as read with Commission Regulation (EU) No 873/2012 on transitional measures concerning the Union list of flavourings and                     source materials set out in Annex I to Regulation (EC) 1334/2008 of the European Parliament and of the Council F13;                  

“authorised officer” means any person who is authorised in writing, either generally or specially, by a food authority to act in matters arising                     under these Regulations;                  

(2) Other expressions used in these Regulations and in the EU instruments listed in paragraph (4) have the same meaning in these                     Regulations as they do in those instruments.                  

(3) Any reference in these Regulations to an Article of or Annex to any of the EU instruments listed in paragraph (4) is a reference                     to that Article or Annex as amended from time to time.                  

(4) The EU instruments are Directive 2009/32, Regulation 2065/2003, Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes                     and food flavourings F14, Regulation 1332/2008, Regulation 1333/2008 and Regulation 1334/2008.                  

(5) The expression “the EU Regulations” means Regulation 2065/2003, Regulation 1332/2008, Regulation 1333/2008 and Regulation 1334/2008.                  

F5OJ L 141, 6.6.2009, p.3. This instrument was last amended by Commission Directive 2010/59/EU (OJ L 225, 27.8.2010, p.10.).

F6OJ L 309, 26.11.2003, p.1. This instrument was amended by Regulation (EC) No 596/2009 of the European Parliament and of the                              Council (OJ L 188, 18.7.2009, p.14).

F7OJ L 354, 31.12.2008, p.7. This instrument was last amended by Commission Regulation (EU) No 1056/2012 (OJ L 313, 13.11.2012,                              p.9).

F8OJ L 354, 31.12.2008, p.16. This instrument was last amended by Commission Regulation (EU) No 739/2013 (OJ L 204, 31.7.2013,                              p.35.).

F9OJ L 295, 12.11.2011, p.1.

F10OJ L 295, 12.11.2011, p.178.

F11OJ L 83, 22.3.2012, p.1. This instrument was last amended by Commission Regulation (EU) No. 497/2013 (OJ L 143, 30.5.2013,                              p.20).

F12OJ L 354, 31.12.2008, p.34. This instrument was last amended by Commission Regulation (EU) No 545/2013 (OJ L 163, 14.06.2013,                              p.15).

F13OJ L 267, 2.10.2012, p.162.

F14OJ L 354, 31.12.2008, p.1. This instrument is implemented by Commission Regulation (EU) No 234/2011 (OJ L 64, 11.03.2011,                              p.15) and that Regulation has been amended by Commission Implementing Regulation (EU) No 562/2012 (OJ L 168, 28.06.12, p.21).

## **PART 2**SFood additives, flavourings and enzymes

### Offence of contravening EU requirements on food additivesS

3.  Any person who contravenes, or who uses or places on the market a product that fails to comply with, any of the provisions                     of Regulation 1333/2008 specified in the first column of Schedule 1, as read with transitional measures contained in or to                     be read with that Regulation, commits an offence.                  

### Offence of contravening EU requirements on flavourings, including smoke flavouringsS

4.  Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions                     of Regulation 1334/2008 specified in the first column of Schedule 2, as read with Article 4 (flavouring substances under evaluation)                     of Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation                     (EC) No 2232/96 of the European Parliament and of the Council F15 and with transitional measures contained in or to be read with Regulation 1334/2008, commits an offence.                  

F15OJ L 267, 2.10.2012, p.1.

### 

5.  Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions                     of Regulation 2065/2003 specified in the first column of Schedule 3, as read with Article 20 (transitional measures) of that                     Regulation, commits an offence.                  

### Offence of contravening EU requirements on food enzymesS

6.  Any person who contravenes, or who uses or places on the market a product which fails to comply with, any of the provisions                     of Regulation 1332/2008 specified in the first column of Schedule 4, as read with Articles 18 and 24 (transitional measures)                     of that Regulation, commits an offence.                  

## **PART 3**SExtraction solvents

### Controls on extraction solventsS

7.  In this Part any reference to a numbered Article or Annex is a reference to that Article of, or Annex to, Directive 2009/32.                  

### 

8.  The provisions of this Part do not apply to any extraction solvent—                  

(a)used in the production of any food additives, vitamins or any other nutritional additives, unless such food additives, vitamins                        or other nutritional additives are listed in Annex I; or                  

(b)intended for export outside the European Union.                  

### 

9.  In this Part “permitted extraction solvent” means—                  

(a)an extraction solvent that—                  

(i)is listed in Annex I;                  

(ii)is used in accordance with the conditions of use and within any maximum residue limits specified in that Annex;                  

(iii)does not contain a toxicologically dangerous amount of any element or substance;                  

(iv)subject to any exceptions deriving from specific purity criteria, does not contain more than 1 mg/kg of arsenic or more than 1 mg/kg lead; and                  

(v)meets the requirements of Article 3(c) as regards purity criteria; or                  

(b)water to which substances regulating acidity or alkalinity may have been added; or                  

(c)food substances which possess solvent properties.                  

### 

10.  No person may use as an extraction solvent in the production of food any extraction solvent that is not a permitted extraction                     solvent.                  

### 

11.—(1) No person may place on the market—                  

(a)an extraction solvent that is not a permitted extraction solvent; or                  

(b)any food having in it or on it an added extraction solvent that is not a permitted extraction solvent.                  

(2) No person may place on the market an extraction solvent that does not meet the requirements of regulation 12.

### 

12.—(1) Subject to paragraph (2), the following information must appear on the packaging, container or label—                  

(a)the commercial name as indicated in Annex I;                  

(b)a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients;                  

(c)a reference by which the batch or lot may be identified;                  

(d)the name or business name and address of the manufacturer or packer or of a seller established in the territory of the EU;                  

(e)the net quantity given as units of volume; and                  

(f)if necessary, the special storage conditions or conditions of use.                  

(2) The particulars specified in subparagraphs (c), (d), (e) and (f) of paragraph (1) may alternatively appear on the trade documents                     relating to the batch or lot which are to be supplied with, or prior to, the delivery.                  

(3) The information specified in paragraph (1) must be easily visible, clearly legible and indelible.

(4) The information specified in paragraph (1) may be provided in more than one language, but at least one of those languages                     must be easily understood by the purchaser unless other measures have been taken to ensure that the purchaser is informed                     of the specified information.                  

## **PART 4**SAdministration and enforcement

### Competent authoritiesS

13.  The competent authority for the purpose of Article 7 of Regulation 2065/2003 is the Food Standards Agency.                  

### Enforcement authoritiesS

14.  It is the duty of each food authority within its area to execute and enforce these Regulations and the EU Regulations.                  

### Offences and penaltiesS

15.—(1) Any person who contravenes regulation 10 or 11 commits an offence.                  

(2) Any person who commits an offence under regulation 3, 4, 5, 6 or 15(1) is liable on summary conviction to a fine not exceeding                     level 5 on the standard scale.                  

### Condemnation of foodS

16.—(1) Paragraph (2) applies where it appears to an authorised officer that—                  

(a)a product fails to comply with any of the requirements specified in the first column of Schedule 1, as read with transitional                        measures contained in or to be read with Regulation 1333/2008;                  

(b)a product fails to comply with any of the requirements specified in the first column of Schedule 2, as read with Article 4                        of Commission Implementing Regulation (EU) No 872/2012 and as read with transitional measures contained in or to be read with                        Regulation 1334/2008;                  

(c)a product fails to comply with any of the requirements specified in the first column of Schedule 3, as read with Article 20                        of Regulation 2065/2003;                  

(d)a product fails to comply with any of the requirements specified in the first column of Schedule 4, as read with Articles                        18 and 24 of Regulation 1332/2008; or                  

(e)a food is placed on the market in contravention of the prohibition in regulation 11(1)(b).                  

(2) Where this paragraph applies, subsections (3) to (9) of section 9 of the Act apply with the following modifications—

(a)references to “food” are to be read as including a reference to “product”;                  

(b)references to “food safety requirements” are to be read as including a reference to—                  

(i)any of the requirements referred to in sub-paragraphs (1)(a) to (d);                  

(ii)the prohibition referred to in sub-paragraph (1)(e).                  

### Application of various provisions of the Food Safety Act 1990S

17.—(1) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in                     those provisions to the Act or Part of it is to be construed as a reference to these Regulations—                  

(a)section 20 (offences due to fault of another person);                  

(b)section 21 (defence of due diligence) F16 with the modification that—                  

(i)subsections (2) to (4) apply in relation to an offence under regulation 3, 4, 5, 6 or 15 as they apply in relation to an offence                        under section 14 or 15; and                  

(ii)in subsection (4) the references to “sale” are deemed to include references to “placing on the market”;                  

(c)section 30(8) (which relates to documentary evidence);                  

(d)section 35(1) (punishment of offences), in so far as it relates to offences under section 33(1) as applied by paragraph (2)(b);                  

(e)section 35(2) and (3) F17, in so far as it relates to offences under section 33(2) as applied by paragraph (2)(c);                  

(f)section 36 (offences by bodies corporate); and                  

(g)section 36A (offences by Scottish partnerships) F18.                  

(2) The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in                     those provisions to the Act is to be construed as including a reference to the EU Regulations and these Regulations—                  

(a)section 3 (presumption that food intended for human consumption) with the modification that the references to “sold” and “sale”                        are deemed to include references to “placed on the market” and “placing on the market” respectively;                  

(b)section 33(1) (obstruction etc. of officers);                  

(c)section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above”                        is deemed to be a reference to any such requirement as is mentioned in that subsection as applied by sub-paragraph (b); and                  

(d)section 44 (protection of officers acting in good faith).                  

(3) Section 34 of the Act (time limit for prosecutions) applies to offences under these Regulations as it applies to offences                     punishable under section 35(2) of the Act.                  

F16Section 21 was amended by S.I. 2004/3279.

F17Section 35(3) was amended by S.I. 2004/3279.

F18Section 36A was inserted by the Food Standards Act 1999 (c.28), **Schedule 5**, paragraph 16.

## **PART 5**SGeneral

### Consequential and other amendmentsS

18.—(1) In regulation 2(1) (interpretation) of the Food Labelling Regulations 1996 F19, in the definition of “the additives regulations” omit “the Food Additives (Scotland) Regulations 2009,”.                  

(2) In regulation 2(1) (interpretation) of the Jam and Similar Products (Scotland) Regulations 2004 F20, in the definition of “permitted sweetener” for the expression “the Food Additives (Scotland) Regulations 2009” substitute                     “ Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives ”.                  

F19S.I. 1996/1499; the relevant amendment is S.S.I. 2010/439.

F20S.S.I. 2004/133; the relevant amendment is S.S.I. 2009/436.

### RevocationsS

19.  The instruments listed in the first column of Schedule 5 are revoked to the extent specified in the second column.                  

MICHAEL MATHESON

 Authorised to sign by the Scottish Ministers

 St Andrew's House,

 Edinburgh

11th September 2013

 Regulation 3

## SCHEDULE 1SSpecified provisions of Regulation 1333/2008

 Regulation 4

## SCHEDULE 2SSpecified provisions of Regulation 1334/2008

 Regulation 5

## SCHEDULE 3SSpecified provisions of Regulation 2065/2003

 Regulation 6

## SCHEDULE 4SSpecified provisions of Regulation 1332/2008

 Regulation 19

## SCHEDULE 5SRevocations

## Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations, which apply to Scotland only, provide for the execution and enforcement of the following EU Regulations—S

(a)Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods;

(b)Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes;

(c)Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

(d)Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for                        use in and on foods.

2.  These Regulations also implement Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents                     used in the production of foodstuffs and food ingredients.S

3.  These Regulations, in Part 2, provide that it is an offence, subject to any applicable transitional arrangements, to contravene                     or to use or place on the market a product that contravenes specified requirements of—S

(a)Regulation (EC) No 1333/2008 relating to food additives (*regulation 3 and Schedule 1*);

(b)Regulation (EC) No 1334/2008 relating to food flavourings and foods with flavouring properties (*regulation 4 and Schedule 2*);

(c)Regulation (EC) No 2065/2003 relating to smoke flavourings (*regulation 5 and Schedule 3*); and

(d)Regulation (EC) No 1332/2008 relating to food enzymes (*regulation 6 and Schedule 4*).

4.  Part 3 of these Regulations implement Directive 2009/32/EC relating to extraction solvents, in particular by—S

(a)specifying the circumstances where the controls on extraction solvents do not apply (*regulation 8*);

(b)defining what constitutes a permitted extraction solvent (*regulation 9*);

(c)prohibiting any person from using an extraction solvent other than a permitted extraction solvent, as defined, in the production                        of food (*regulation 10*);

(d)prohibiting any person from placing on the market an extraction solvent that is not a permitted extraction solvent or which                        is not accompanied by certain information on the packaging, container or label (*regulations 11 and 12*).

5.  These Regulations in Part 4—S

(a)designate the Food Standards Agency as the competent authority for the purposes of applications for authorisation of a smoke                        flavouring (*regulation 13*);

(b)assign the duty of enforcing these Regulations to food authorities (*regulation 14*);

(c)provide for the maximum penalty to which a person may be liable on conviction for an offence under these Regulations (*regulation 15*);

(d)provide that, where it appears to an authorised officer that a product fails to comply with certain requirements or that food                        is placed on the market contrary to a specified prohibition, the food will be treated for the purposes of subsections (3)                        to (9) of section 9 of the Food Safety Act 1990 (with certain modifications) as failing to comply with food safety requirements                        (*regulation 16*); and

(e)apply, with certain modifications, various provisions of the Food Safety Act 1990 for the purposes of these Regulations (*regulation 17*).

6.  These Regulations in Part 5—S

(a)make a minor amendment to the Food Labelling Regulations 1996 (*regulation 20*) and the Jam and Similar Products (Scotland) Regulations 2004; and

(b)revoke certain instruments in whole or in part (*regulation 19 and Schedule 5*).

7.  A business and regulatory impact assessment has not been prepared for this instrument as no impact on business or the public                     or third sectors is foreseen.S