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

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Welsh Statutory Instruments

# 2013 No. 2591 (W. 255)

Food, Wales

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

Made

7 October 2013

Laid before the National Assembly for Wales

9 October 2013

Coming into force

31 October 2013

The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16(1)(a),(e) and (f),17(1)                           and (2), 26(1), (2)(e) and (f) and (3), and 48(1) of the Food Safety Act 1990 F1 and now vested in them F2,as read with paragraph 1A of Schedule 2 to the European Communities Act 1972 F3.                        

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

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears                           to the Welsh 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.                        

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, there has been open and transparent public consultation during the preparation and evaluation of these Regulations.                        

F11990 c. 16. Section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990. Sections 17 and 48 were amended by paragraphs 12 and 21 respectively of 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.

F2Functions of “the Ministers”, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales                              by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the Food Standards Act 1999 (c.28), and subsequently transferred to the Welsh Ministers by paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c.32).

F31972 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).

F4OJ No. L31, 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 No. L188, 18.7.2009, p14).

## **PART 1**E+WIntroductory

### Title, application and commencementE+W

1.  The title of these Regulations is the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013,                     they apply in relation to Wales and come into force on 31 October 2013.                  

### InterpretationE+W

2.—(1) In these Regulations —                  

“the Act” (“*y Ddeddf*”) means the Food Safety Act 1990;                  

“Directive 2009/32” (“*Cyfarwyddeb 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” (“*Rheoliad 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” (“*Rheoliad 1332/2008*”) means Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes F7;                  

“Regulation 1333/2008” (“*Rheoliad 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” (“*Rheoliad 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” (“*swyddog awdurdodedig*”) means any person who is authorised in writing, either generally or specially, by a food authority to act in matters arising                     under these Regulations;                  

“food authority” (“*awdurdod bwyd*”) means —                  

a county council; and

a county borough council;

“the EU Regulations” means Regulation 2065/2003, Regulation 1332/2008, Regulation 1333/2008 and Regulation 1334/2008.                  

(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) Where any functions under the Act are assigned —

(a)by an order under section 2 of the Public Health (Control of Disease) Act 1984 F15, to a port health authority; or                  

(b)by an order under section 6 of the Public Health Act 1936 F16, to a joint board for a united district;                  

any reference in these Regulations to a food authority is to be construed, so far as relating to those functions, as a reference                     to the authority to which they are so assigned.                  

F5OJ No. L141, 6.6.2009, p.3. This instrument was amended by Commission Directive 2010/59/EU (OJ No. L225, 27.8.2010, p.10).

F6OJ No. L309, 26.11.2003, p.1. This instrument was amended by Regulation (EC) No 596/2009 of the European Parliament and of                              the Council (OJ No. L188, 18.7.2009, p.14).

F7OJ No. L354, 31.12.2008, p.7. This instrument was last amended by Commission Regulation (EU) No 1056/2012 (OJ No. L313, 13.11.2012,                              p.9).

F8OJ No. L354, 31.12.2008, p.16. This instrument was last amended by Commission Regulation (EU) No. 510/2013 (OJ No. L150, 4.6.2013,                              p.17).

F9OJ No. L295, 12.11.2011, p.1.

F10OJ No. L295, 12.11.2011, p.178.

F11OJ No. L83, 22.3.2012, p.1. This instrument was last amended by Commission Regulation (EU) No. 497/2013 (OJ No. L143, 30.5.2013,                              p.20).

F12OJ No. L354, 31.12.2008, p.34. This instrument was last amended by Commission Implementing Regulation (EU) No 545/2013 (OJ                              No. L163, 15.6.2013, p.15).

F13OJ No. L267, 2.10.2012, p.162.

F14OJ No. L354, 31.12.2008, p.1. This instrument is implemented by Commission Regulation (EU) No. 234/2011 (OJ No. L64, 11.03.2011,                              p.15) and that Regulation has been amended by Commission Implementing Regulation (EU) No. 562/2012 (OJ No. L168, 28.06.2012,                              p.2).

F151984 c.22; section 7(3)(d) was substituted by paragraph 27 of Schedule 3 to the Food Safety Act 1990 (1990 c.16).

F161936 c.49; section 6 is to be read with paragraph 1 of Schedule 3 to the Food Safety Act 1990.

## **PART 2**E+WFood additives, flavourings and enzymes

### Offence of contravening EU requirements on food additivesE+W

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 Table 1 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 flavouringsE+W

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 Table 1 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 F17 and with transitional measures contained in or to be read with Regulation 1334/2008, commits an offence.                  

F17OJ No. L267, 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 Table 1 of Schedule 3 commits an offence.                  

### Offence of contravening EU requirements on food enzymesE+W

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 Table 1 of Schedule 4, as read with Articles 18 and 24 (transitional                     measures), commits an offence.                  

### Improvement notices – application of subsections (1) and (2) of section 10 of the Food Safety Act 1990E+W

7.—(1) Subsections (1) and (2) of section 10 of the Act (improvement notices) apply for the purposes of these Regulations with the                     following modifications.                  

(2) For subsection (1), substitute—

“(1)If an authorised officer of an enforcement authority has reasonable grounds for believing that a person is failing to comply                        with a provision of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013 specified in                        paragraph (1A), the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)—                  

(a)state the officer's grounds for believing that the person is failing to comply with the relevant provision;                  

(b)specify the matters which constitute the person's failure so to comply;                  

(c)specify the measures which, in the officer's opinion, the person must take in order to secure compliance; and                  

(d)require the person to take those measures, or measures that are at least equivalent to them, within such period as may be                           specified in the notice.                  

(1A)Any EU provision specified in the first column of Table 2 of—                  

(a)Schedule 1;                  

(b)Schedule 2;                  

(c)Schedule 3; or                  

(d)Schedule 4; or                  

(e)regulation 13(2)”.                  

### Appeal against improvement notice – application of subsections (1) and (6) of sections 37 and section 39 of the Food Safety                     Act 1990E+W

8.—(1) Subsections (1) and (6) of section 37 of the Act (appeals) apply for the purposes of these Regulations with the following                     modifications—                  

(a)for subsection (1), substitute—                  

“(1)Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice                        under section 10(1), as applied and modified by regulation 7 of the Food Additives, Flavourings, Enzymes and Extraction Solvents                        (Wales) Regulations 2013, may appeal to a magistrates court.”; and                  

(b)in subsection (6), for “(3) or (4)”, substitute “ (1), (3) or (4) ”.                  

## **PART 3**E+WExtraction solvents

### Controls on extraction solventsE+W

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

### 

10.  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.                  

### 

11.  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.                  

### 

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

### 

13.—(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 14.

### 

14.—(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**E+WAdministration and enforcement

### Competent authoritiesE+W

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

### Enforcement authoritiesE+W

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

### Offences and penaltiesE+W

17.—(1) Any person who contravenes regulation 12 or 13(1) commits an offence.                  

(2) Any person guilty of an offence under regulation 3, 4, 5, 6 or 17(1) is liable on summary conviction to a fine not exceeding                     level 5 on the standard scale.                  

### Condemnation of foodE+W

18.  Where any food is certified by a food analyst as being food which it is an offence to place on the market, that food shall                     be treated for the purposes of section 9 of the Act (under which food may be seized and destroyed under an order of a justice                     of the peace) as failing to comply with food safety requirements.                  

### Application of various provisions of the Food Safety Act 1990E+W

19.—(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) F18 with the modification that —                  

(i)subsections (2) to (4) shall apply in relation to an offence under regulation 3, 4, 5, 6, 7(4) or 17(1) 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) F19, in so far as it relates to offences under section 33(1) as applied by paragraph (3)(b);                  

(e)section 35(2) and (3) F20, in so far as it relates to offences under section 33(2) as applied by paragraph (1)(c);                  

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

(g)section 36A (offences by Scottish partnerships) F21.                  

(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 is 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.                  

F18Section 21 was amended by S.I. 2004/3279.

F19Section 35(1) is amended by the Criminal Justice Act 2003 (c.44), **Schedule 26**, paragraph 42, from a date to be appointed.

F20Section 35(3) was amended by S.I. 2004/3279.

F21Section 36A was inserted by the Food Standards Act 1999 (c.28), **Schedule 5**, paragraph 16.

## **PART 5**E+WGeneral

### Consequential and other amendmentsE+W

20.  In regulation 2(1) (interpretation) of the Food Labelling Regulations 1996 F22, in the definition of “the additives regulations” omit the expression “the Food Additives (Wales) Regulations 2009,”.                  

F22S.I. 1996/1499. Relevant amending instruments are S.I. 2010/2817 and 2012/2619.

### RevocationsE+W

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

Mark Drakeford

 Minister for Health and Social Services, one of the Welsh Ministers

7 October 2013

 Regulations 3 and 7

## SCHEDULE 1E+WSpecified provisions of Regulation 1333/2008

### Table 1

### Table 2

 Regulations 4 and 7

## SCHEDULE 2E+WSpecified provisions of Regulation 1334/2008

### Table 1

### Table 2

 Regulations 5 and 7

## SCHEDULE 3E+WSpecified provisions of Regulation 2065/2003

### Table 1

### Table 2

 Regulations 6 and 7

## SCHEDULE 4E+WSpecified provisions of Regulation 1332/2008

### Table 1

### Table 2

 Regulation 21

## SCHEDULE 5E+WRevocations

## Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations, which apply to Wales, provide for the execution and enforcement of the following EU Regulations —E+W

(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 (OJ No. L309,                        26.11.2003, p.1);

(b)Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes (OJ No. L354, 31.12.2008, p.7);

(c)Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ No. L354, 31.12.2008, p.16);

(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 (OJ No. L354, 31.12.2008, p.34).

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 (OJ No. L141, 6.6.2009, p.3).E+W

3.  These Regulations revoke, in whole or in part, the following Regulations —E+W

(a)The Extraction Solvents in Food Regulations 1993 (S.I. 1993/1658);

(b)The Smoke Flavourings (Wales) Regulations 2005 (S.I. 2005/1350 (W.98));

(c)The Food (Suspension of the Use of E128 Red 2G Food Colour) (Wales) Regulations 2007 (S.I. 2007/23315 (W.186));

(d)The Food Enzymes (Wales) Regulations 2009 (S.I. 2009/3377 (W.299));

(e)The Food Additives (Wales) Regulations 2009 (S.I. 2009/3378 (W.300));

(f)The Flavourings in Food (Wales) Regulations 2010 (S.I. 2010/1198 (W.2922)).

4.  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 —E+W

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

(b)Regulation (EC) No 1334/2008 relating to food flavourings and foods with flavouring properties (*regulation 4 and Table 1 of Schedule 2*);

(c)Regulation (EC) No 2065/2003 relating to smoke flavourings (*regulation 5 and Table 1 of Schedule 3*); and

(d)Regulation (EC) No 1332/2008 relating to food enzymes (*regulation 6 and Table 1 of Schedule 4*).

5.  These Regulations also provide in Part 2 that in the case of certain types of non-compliance, relating to labelling, an authorised                     officer of an enforcement authority may serve an improvement notice requiring specified steps to be taken, failing which an                     offence will be committed (*regulation 7 and Table 2 of Schedules 1 to 4*). A person served with an improvement notice may appeal against it to a magistrates court (*regulation 8*).E+W

6.  Part 3 of these Regulations implement Directive 2009/32/EC relating to extraction solvents, in particular by —E+W

(a)specifying the circumstances where the controls on extraction solvents do not apply (*regulation 10*);

(b)defining what constitutes a permitted extraction solvent (*regulation 11*);

(c)prohibiting any person from using an extraction solvent other than a permitted extraction solvent, as defined, in the production                        of food (*regulation 12*);

(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 13 and 14*).

7.  These Regulations in Part 4 —E+W

(a)designate the Food Standards Agency as the competent authority for the purposes of applications for authorisation of a smoke                        flavouring (*regulation 15*);

(b)assign the duty of enforcing these Regulations to food authorities (*regulation 16*);

(c)provide for the maximum penalty to which a person may be liable on conviction for an offence under these Regulations (*regulation 17*);

(d)provide that, where food is certified as being food which it is an offence to place on the market, the food will be treated                        for the purposes of section 9 of the Food Safety Act 1990 as failing to comply with food safety requirements (*regulation 18*); and

(e)apply, with certain modifications, various provisions of the Food Safety Act 1990 for the purposes of these Regulations (*regulation 19*).

8.  These Regulations in Part 5 —E+W

(a)make a minor amendment to the Food Labelling Regulations 1996 (*regulation 20*); and

(b)revoke certain instruments in whole or in part (*regulation 21 and Schedule 5*).

9.  The Welsh Ministers' Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these                     Regulations. As a result it was not considered necessary to carry out a regulatory impact assessment as to the likely costs                     and benefits of complying with these Regulations.E+W