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Regulation (EC) No 1331/2008 of the European Parliament and of the Council

of 16 December 2008

establishing a common authorisation procedure for food additives, food enzymes and food flavourings

(Text with EEA relevance)cross-notes

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3) In order to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market.

(4) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives(3), Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes(4) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods(5) (hereinafter referred to as the sectoral food laws) lay down harmonised criteria and requirements concerning the assessment and authorisation of these substances.

(5) It is envisaged, in particular, that food additives, food enzymes and food flavourings, to the extent that the safety of food flavourings must be assessed in accordance with Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods], must not be placed on the market or used in foodstuffs for human consumption, in accordance with the conditions laid down in each sectoral food law, unless they are included on a Community list of authorised substances.

(6) Ensuring transparency in the production and handling of food is absolutely crucial in order to maintain consumer confidence.

(7) In this context, it appears appropriate to establish for these three categories of substances a common Community assessment and authorisation procedure that is effective, time-limited and transparent, so as to facilitate their free movement within the Community market.

(8) This common procedure must be founded on the principles of good administration and legal certainty and must be implemented in compliance with those principles.

(9) This Regulation will thus complete the regulatory framework concerning the authorisation of the substances by laying down the various stages of the procedure, the deadlines for those stages, the role of the parties involved and the principles that apply. Nevertheless, for some aspects of the procedure, it is necessary to take the specific characteristics of each sectoral food law into consideration.

(10) The deadlines laid down in the procedure take into account the time needed to consider the different criteria set in each sectoral food law, as well as allowing adequate time for consultation when preparing the draft measures. In particular, the nine-months deadline for the Commission to present a draft regulation updating the Community list should not preclude the possibility of this being done within a shorter period.

(11) Upon receipt of an application the Commission should initiate the procedure and where necessary seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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(6) as soon as possible after the validity and applicability of the application have been assessed.

(12) In accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002, the authorisation to place substances on the market must be preceded by an independent scientific assessment, of the highest possible standard, of the risks that they pose to human health. This assessment, which must be carried out under the responsibility of the Authority, must be followed by a risk management decision taken by the Commission under a regulatory procedure that ensures close cooperation between the Commission and the Member States.

(13) The authorisation to place substances on the market should be granted pursuant to this Regulation provided that the criteria for authorisation laid down under the sectoral food laws are satisfied.

(14) It is recognised that, in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account, including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.

(15) In order to ensure that both business operators in the sectors concerned and the public are kept informed of the authorisations in force, the authorised substances should be included on a Community list created, maintained and published by the Commission.

(16) Where appropriate and under certain circumstances, the specific sectoral food law may provide for protection of scientific data and other information submitted by the applicant for a certain period of time. In this case, the sectoral food law should lay down the conditions under which these data may not be used for the benefit of another applicant.

(17) Networking between the Authority and the Member States’ organisations operating in the fields within the Authority’s mission is one of the basic principles of the Authority’s operation. In consequence, in preparing its opinion, the Authority may use the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by Commission Regulation (EC) No 2230/2004(7).

(18) The common authorisation procedure for the substances must fulfil transparency and public information requirements while guaranteeing the right of applicants to preserve the confidentiality of certain information.

(19) Protecting the confidentiality of certain aspects of an application should be maintained as a consideration in order to protect the competitive position of an applicant. However, information relating to the safety of a substance, including, but not limited to, toxicological studies, other safety studies and raw data as such, should under no circumstances be confidential.

(20) Pursuant to Regulation (EC) No 178/2002, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(8) applies to documents held by the Authority.

(21) Regulation (EC) No 178/2002 establishes procedures for taking emergency measures in relation to foodstuffs of Community origin or imported from third countries. It authorises the Commission to adopt such measures in situations where foodstuffs are likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.

(22) In the interests of efficiency and legislative simplification, there should be a medium-term examination of the question whether to extend the scope of the common procedure to other legislation in the area of food.

(23) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States on account of differences between national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(24) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).

(25) In particular the Commission should be empowered to update the Community lists. Since those measures are of general scope and are designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(26) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the addition of substances to the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists.

(27) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the removal of a substance from the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists,

HAVE ADOPTED THIS REGULATION:

CHAPTER I GENERAL PRINCIPLES

Article 1 Subject matter and scope

1.F1This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the common procedure) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs (hereinafter referred to as the substances), which contributes to the free movement of food ... and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests. This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods(10).

2.The common procedure shall lay down the procedural arrangements for [F2determining the authorisation statusF2] of substances [F3for the purposes ofF3] Regulation (EC) No 1333/2008 [on food additives], Regulation (EC) No 1332/2008 [on food enzymes] and Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods] (hereinafter referred to as the sectoral food laws).

3.The criteria according to which substances can be [F4authorisedF4] and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.

Article 2 [F5DefinitionsF5]

F61.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F62.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7 3. “ Authority ” means—

(a)as regards England and Wales, the Food Standards Agency;

(b)as regards Scotland, Food Standards Scotland;

4. “prescribe”, means prescribe by regulations;

5. “ appropriate authority ” means—

(a)in relation to England, the Secretary of State;

(b)in relation to Wales, the Welsh Ministers;

(c)in relation to Scotland, the Scottish Ministers;

6. “ Regulation 234/2011 ” means Commission Implementing Regulation (EU) No. 234/2011 implementing 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; F7]

[F8 7. ‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008 . F8]

[F9Article 2A Requirement for appropriate authority to determine authorisation status

The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.

Article 2B Determination of authorisation status

1.For the purposes of this Regulation, determining the authorisation status of a substance is to consist of the appropriate authority determining whether or not to:

(a)authorise the placing on the market, or the use in or on food, of a substance;

(b)modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned;

(c)revoke or suspend the authorisation of a substance.

2.For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—

(a)existing stocks of the substance concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the substance concerned, and any products derived from it or containing it, may continue to be applied.

3.The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation under the sectoral food law concerned and this Regulation.

4. In this Article, “ authorisation ” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008 ; and related terms are to be construed accordingly.

Article 2C Domestic list of substances

1. The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation.

2.The Authority must make the domestic list available to the public.F9]

CHAPTER II COMMON PROCEDURE

Article 3 Main stages of the common procedure

1.F12The common procedure for [F10determining the authorisation status of a substanceF10] may be started either on the initiative of the [F11AuthorityF11] or following an application. Applications may be made ... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by [F13Regulation 234/2011F13] . Applications shall be sent to the [F14appropriate authorityF14] .

2.The [F15appropriate authorityF15] shall seek the opinion of the [F16AuthorityF16] , to be given in accordance with Article 5.

However, for [F17a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)F17] , the [F15appropriate authorityF15] shall not be required to seek the opinion of the Authority if [F18any changes as a result of the determinationF18] in question are not liable to have an effect on human health.

[F193.The common procedure is to end with the appropriate authority [F20determining the authorisation status of the substance concernedF20] , in accordance with Article 7.F19]

4.F24By way of derogation from paragraph 3, the [F21appropriate authorityF21] may end the common procedure and decide not to proceed with [F22determining the authorisation status of a substanceF22] , at any stage of the procedure, if it judges that such [F23a determinationF23] is not justified. Where applicable, it shall take account of the opinion of the Authority, ..., any relevant provisions of [F25assimilatedF25] law and any other legitimate factors relevant to the matter under consideration.

F27In such cases, where applicable, the [F26appropriate authorityF26] shall inform the applicant ... directly, indicating in its letter the reasons for not [F28determining the authorisation status of the substance concernedF28] .

Article 4 Initiating the procedure

1.On receipt of an application to [F29determine the authorisation status of a substanceF29] , the [F30appropriate authorityF30] :

(a)shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;

(b)where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).

F31...

F322.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 5 Opinion of the Authority

1.The Authority shall give its opinion within nine months of receipt of a valid application.

2.The Authority shall forward its opinion to the [F33appropriate authorityF33] and, where applicable, the applicant.

Article 6 Additional information concerning risk assessment

1.F34In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided ....

2.If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.

3.F35Where applicants submit additional information on their own initiative, they shall send it to the Authority .... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.

F364.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 7 [F37Determination of authorisation status and amendment of sectoral food lawsF37]

[F381.Within nine months of receiving the opinion of the Authority, the appropriate authority must [F39determine the authorisation status of the substance concerned,F39] taking into account the opinion of the Authority, any relevant provisions of [F40assimilatedF40] law and any other legitimate factors relevant to the matter under consideration.

In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.F38]

[F411A.Where the appropriate authority makes a determination as to the authorisation status of a substance:

(a)the appropriate authority must:

(i)specify the date on which the authorisation, modification, suspension or revocation is to have effect; and

(ii)communicate the determination to the Authority;

(b)the Authority must update the domestic list referred to in Article 2C accordingly.F41]

F422.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F433.Where the [F44determinationF44] is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its [F44determinationF44] .F43]

4.The measures, designed to amend non-essential elements of each sectoral food law, relating to the [F45revocation of the authorisation of substances generallyF45] , [F46may be prescribed by the appropriate authority after seeking advice from the AuthorityF46] .

5.On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the [F47authorisation of substances generallyF47] and for [F48modifyingF48] conditions, specifications or restrictions associated with the [F49authorisation of substances generallyF49] , [F50may be prescribed by the appropriate authority after seeking advice from the AuthorityF50] .

F516.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 8 Additional information concerning risk management

1.F53Where the [F52AuthorityF52] requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. ...

2.If the additional information is not sent within the additional period referred to in paragraph 1, the [F54AuthorityF54] shall act on the basis of the information already provided.

CHAPTER III MISCELLANEOUS PROVISIONS

Article 9 Implementing measures

1.F55... The implementing measures for this Regulation [F56may be prescribed by the appropriate authority after seeking advice from the AuthorityF56] , and shall concern in particular:

(a)the content, drafting and presentation of the application referred to in Article 4(1);

(b)the arrangements for checking the validity of applications;

(c)the type of information that must be included in the opinion of the Authority referred to in Article 5.

F572.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 10 Extension of time periods

F59,F60In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the [F58AuthorityF58] on its own initiative ..., if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases the [F58AuthorityF58] shall, where appropriate, inform the applicant ... of the extension and the reasons for it.

Article 11 Transparency

The Authority [F61mustF61] make its opinions public without delay. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1).

Article 12 Confidentiality

1.Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position.

Information relating to the following shall not, in any circumstances, be regarded as confidential:

(a)the name and address of the applicant;

(b)the name and a clear description of the substance;

(c)the justification for the use of the substance in or on specific foodstuffs or food categories;

(d)information that is relevant to the assessment of the safety of the substance;

(e)where applicable, the analysis method(s).

2.For the purposes of implementing paragraph 1, applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases.

3.F63The [F62AuthorityF62] shall decide after consulting with the applicants which information can remain confidential and shall notify applicants ... accordingly.

4.After being made aware of the [F64Authority'sF64] position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires.

F655.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.If an applicant withdraws, or has withdrawn, its application, the [F66appropriate authority and the AuthorityF66] shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the [F67AuthorityF67] and the applicant.

7.The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the [F68appropriate authority and the AuthorityF68] .

F69Article 13 Emergencies

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F70Article 14 Committee

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F71Article 14A Regulations and devolved powers

1.Any power to make regulations under this Regulation—

(a)so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.

2.Any power to make regulations under this Regulation includes power—

(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);

(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

3. Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—

(a)in the case of England, of either House of Parliament;

(b)in the case of Wales, of Senedd Cymru;

(c)in the case of Scotland, of the Scottish Parliament.

4.In this Regulation, any power—

(a)of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.F71]

F72Article 15 Competent authorities of the Member States

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER IV FINAL PROVISION

Article 16 Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

For each sectoral food law, it shall apply from the date of application of the measures referred to in Article 9(1).

Article 9 shall apply from 20 January 2009.

F73...

Done at Strasbourg, 16 December 2008.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

B. Le Maire

(1)

OJ C 168, 20.7.2007, p. 34.

(2)

Opinion of the European Parliament of 10 July 2007 (OJ C 175 E, 10.7.2008, p. 134), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008.

(3)

See page 16 of this Official Journal.

(4)

See page 7 of this Official Journal.

(5)

See page 34 of this Official Journal.

(6)

OJ L 31, 1.2.2002, p. 1.

(7)

Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission (OJ L 379, 24.12.2004, p. 64).

(8)

OJ L 145, 31.5.2001, p. 43.

(9)

OJ L 184, 17.7.1999, p. 23.

(10)

OJ L 309, 26.11.2003, p. 1.

(1)

OJ C 168, 20.7.2007, p. 34.

(2)

Opinion of the European Parliament of 10 July 2007 (OJ C 175 E, 10.7.2008, p. 134), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008.

(3)

See page 16 of this Official Journal.

(4)

See page 7 of this Official Journal.

(5)

See page 34 of this Official Journal.

(6)

OJ L 31, 1.2.2002, p. 1.

(7)

Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission (OJ L 379, 24.12.2004, p. 64).

(8)

OJ L 145, 31.5.2001, p. 43.

(9)

OJ L 184, 17.7.1999, p. 23.

(10)

OJ L 309, 26.11.2003, p. 1.

Status: There are currently no known outstanding effects by UK legislation for Regulation (EC) No 1331/2008 of the European Parliament and of the Council.
Regulation(EC) No 1331/2008of the European Parliament and of the Council ()
Version from: 1 April 2025

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Status of this instrument

in force Provision is in force
in force* In force only for specified purposes (see footnote)
not in force Not in force in England (may be in force in other geographies, see footnotes)
defined term Defined term
dfn Defined term (alternative style)
footnote commentary transitional and savings in force status related provisions geo extent insert/omit source count in force adj
C1 Regulation applied (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)
F1 Words in Art. 1(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 37(a); 2020 c. 1, Sch. 5 para. 1(1) omitted
F2 Words in Art. 1(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(2)(a)(i) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F3 Words in Art. 1(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(2)(a)(ii) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F4 Words in Art. 1(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(2)(b) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F5 Art. 2 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(3)(a) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F6 Art. 2(1)(2) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(3)(b) (with reg. 23) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F7 Art. 2(3)-(6) added (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 39(c) (as amended by S.I. 2020/1504, regs. 1(2), 18(10)); 2020 c. 1, Sch. 5 para. 1(1) added
F8 Art. 2(7) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(3)(c) (with reg. 23) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F9 Arts. 2A-2C inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(4) (with reg. 23) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F9 Arts. 2A-2C inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(4) (with reg. 23) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F9 Arts. 2A-2C inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(4) (with reg. 23) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F10 Words in Art. 3(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(a) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F11 Word in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F12 Words in Art. 3(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(iii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F13 Words in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(iv); 2020 c. 1, Sch. 5 para. 1(1) substituted
F14 Words in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(v); 2020 c. 1, Sch. 5 para. 1(1) substituted
F15 Words in Art. 3(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(b)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F16 Word in Art. 3(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(b)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F17 Words in Art. 3(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(b)(i) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F18 Words in Art. 3(2) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(b)(ii) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F19 Art. 3(3) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(c); 2020 c. 1, Sch. 5 para. 1(1) substituted
F20 Words in Art. 3(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(c) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F21 Words in Art. 3(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(d)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F22 Words in Art. 3(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(d)(i)(aa) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F23 Words in Art. 3(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(d)(i)(bb) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F24 Words in Art. 3(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(d)(ii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F25 Word in Art. 3(4) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 12(a) substituted
F26 Words in Art. 3(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(e)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F27 Words in Art. 3(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(e)(ii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F28 Words in Art. 3(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(5)(d)(ii) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F29 Words in Art. 4(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(6) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F30 Words in Art. 4(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 41(a)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F31 Words in Art. 4(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 41(a)(iii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F32 Art. 4(2) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 41(b); 2020 c. 1, Sch. 5 para. 1(1) omitted
F33 Words in Art. 5(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 42; 2020 c. 1, Sch. 5 para. 1(1) substituted
F34 Words in Art. 6(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 43(a); 2020 c. 1, Sch. 5 para. 1(1) omitted
F35 Words in Art. 6(3) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 43(b); 2020 c. 1, Sch. 5 para. 1(1) omitted
F36 Art. 6(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 43(c); 2020 c. 1, Sch. 5 para. 1(1) omitted
F37 Art. 7 heading substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(a) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F38 Art. 7(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(a); 2020 c. 1, Sch. 5 para. 1(1) substituted
F39 Words in Art. 7(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(b) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F40 Word in Art. 7(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 12(b) substituted
F41 Art. 7(1A) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(c) (with reg. 23) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F42 Art. 7(2) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(b); 2020 c. 1, Sch. 5 para. 1(1) omitted
F43 Art. 7(3) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(c); 2020 c. 1, Sch. 5 para. 1(1) substituted
F44 Word in Art. 7(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(d) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F45 Words in Art. 7(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(e) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F46 Words in Art. 7(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(d); 2020 c. 1, Sch. 5 para. 1(1) substituted
F47 Words in Art. 7(5) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(f)(i) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F48 Word in Art. 7(5) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(f)(ii) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F49 Words in Art. 7(5) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 6(7)(f)(iii) (with reg. 23) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F50 Words in Art. 7(5) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(e)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F51 Art. 7(6) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 45(f); 2020 c. 1, Sch. 5 para. 1(1) omitted
F52 Word in Art. 8(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 46(a)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F53 Words in Art. 8(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 46(a)(ii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F54 Word in Art. 8(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 46(b); 2020 c. 1, Sch. 5 para. 1(1) substituted
F55 Words in Art. 9(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 47(a)(i); 2020 c. 1, Sch. 5 para. 1(1) omitted
F56 Words in Art. 9(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 47(a)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F57 Art. 9(2) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 47(b); 2020 c. 1, Sch. 5 para. 1(1) omitted
F58 Word in Art. 10 substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 48(a); 2020 c. 1, Sch. 5 para. 1(1) substituted
F59 Words in Art. 10 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 48(b); 2020 c. 1, Sch. 5 para. 1(1) omitted
F60 Words in Art. 10 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 48(c); 2020 c. 1, Sch. 5 para. 1(1) omitted
F61 Word in Art. 11 substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 49; 2020 c. 1, Sch. 5 para. 1(1) substituted
F62 Word in Art. 12(3) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(a)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F63 Words in Art. 12(3) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(a)(ii); 2020 c. 1, Sch. 5 para. 1(1) omitted
F64 Word in Art. 12(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(b); 2020 c. 1, Sch. 5 para. 1(1) substituted
F65 Art. 12(5) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(c); 2020 c. 1, Sch. 5 para. 1(1) omitted
F66 Words in Art. 12(6) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(d)(i); 2020 c. 1, Sch. 5 para. 1(1) substituted
F67 Word in Art. 12(6) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(d)(ii); 2020 c. 1, Sch. 5 para. 1(1) substituted
F68 Words in Art. 12(7) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 50(e); 2020 c. 1, Sch. 5 para. 1(1) substituted
F69 Art. 13 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 51; 2020 c. 1, Sch. 5 para. 1(1) omitted
F70 Art. 14 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 51; 2020 c. 1, Sch. 5 para. 1(1) omitted
F71 Art. 14A inserted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 52 (as amended by S.I. 2020/1504, regs. 1(2), 18(11)); 2020 c. 1, Sch. 5 para. 1(1) inserted
F72 Art. 15 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 53; 2020 c. 1, Sch. 5 para. 1(1) omitted
F73 Words in Signature omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 54; 2020 c. 1, Sch. 5 para. 1(1) omitted
Defined Term Section/Article ID Scope of Application
appropriate authority art. Article 2 of CHAPTER I def_e035dde2f0
authorisation art. Article 2B of CHAPTER I def_4b9049db99
Authority art. Article 2 of CHAPTER I def_9ccc81e9f8
domestic list art. Article 2C of CHAPTER I def_6dbcebe178
prescribe art. Article 2 of CHAPTER I def_1cd010c8f3
Regulation 234/2011 art. Article 2 of CHAPTER I def_ad5c065e79
Substance art. Article 2 of CHAPTER I def_d79c26741a

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.

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