Regulation (EC) No 1331/2008 of the European Parliament and of the CouncilShow full title

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)

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:

Modifications etc. (not altering text)

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)

CHAPTER I U.K. GENERAL PRINCIPLES

Article 1 U.K. Subject matter and scope

1. This 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 F1 ... 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 updating the lists of substances the marketing of which is authorised F2 ... pursuant to 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 included on the [F3 domestic] list provided for in Article 2, the content of the regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.

Textual Amendments

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)

F2 Words in Art. 1(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, 37(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in Art. 1(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, 37(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. [F4 Domestic] list of substances

1. Under each sectoral food law, substances that have been authorised to be placed on the F5 ... market shall be included on a list the content of which is determined by the said law (hereinafter referred to as the [F6 domestic] list). [F7 The domestic list is to be updated by the appropriate authority.] F8 ...

2. ‘Updating the [F9 domestic] list’ means:

(a) adding a substance to the [F9 domestic] list;

(b) removing a substance from the [F9 domestic] list;

(c) adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the [F9 domestic] list.

[F10 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;]

Textual Amendments

F4 Word in Art. 2 heading 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, 38; 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Art. 2(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, 39(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 2(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, 39(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 2(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, 39(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 2(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, 39(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 2(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, 39(b); 2020 c. 1, Sch. 5 para. 1(1)

F10 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)

CHAPTER II U.K. COMMON PROCEDURE

Article 3 U.K. Main stages of the common procedure

1. The common procedure for updating the [F11 domestic] list may be started either on the initiative of the [F12 Authority] or following an application. Applications may be made F13 ... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by [F14 Regulation 234/2011]. Applications shall be sent to the [F15 appropriate authority].

2. The [F16 appropriate authority] shall seek the opinion of the [F17 Authority], to be given in accordance with Article 5.

However, for the updates referred to in Article 2(2)(b) and (c), the [F16 appropriate authority] shall not be required to seek the opinion of the Authority if the updates in question are not liable to have an effect on human health.

[F18 3. The common procedure is to end with the appropriate authority prescribing the update, in accordance with Article 7.]

4. By way of derogation from paragraph 3, the [F19 appropriate authority] may end the common procedure and decide not to proceed with a planned update, at any stage of the procedure, if it judges that such an update is not justified. Where applicable, it shall take account of the opinion of the Authority, F20 ..., any relevant provisions of [F21 retained EU] law and any other legitimate factors relevant to the matter under consideration.

In such cases, where applicable, the [F22 appropriate authority] shall inform the applicant F23 ... directly, indicating in its letter the reasons for not considering the update justified.

Textual Amendments

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)(i); 2020 c. 1, Sch. 5 para. 1(1)

F12 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)

F13 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)

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)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F15 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)

F16 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)

F17 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)

F18 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)

F19 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)

F20 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)

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)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F22 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)

F23 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)

Article 4 U.K. Initiating the procedure

1. On receipt of an application to update the [F24 domestic] list, the [F25 appropriate authority]:

(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).

F26 ...

F27 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24 Word 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)(i); 2020 c. 1, Sch. 5 para. 1(1)

F25 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)

F26 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)

F27 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)

Article 5 U.K. 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 [F28 appropriate authority] and, where applicable, the applicant.

Textual Amendments

F28 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)

Article 6 U.K. Additional information concerning risk assessment

1. In 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 F29 ....

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. Where applicants submit additional information on their own initiative, they shall send it to the Authority F30 .... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.

F31 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F29 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)

F30 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)

F31 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)

Article 7 U.K. Updating the [F32 domestic] list

[F33 1. Within nine months of receiving the opinion of the Authority, the appropriate authority must take the decision whether to update the domestic list taking into account the opinion of the Authority, any relevant provisions of retained EU 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.]

F34 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F35 3. Where the decision is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its decision.]

4. The measures, designed to amend non-essential elements of each sectoral food law, relating to the removal of a substance from the [F36 domestic] list, [F37 may be prescribed by the appropriate authority after seeking advice from the Authority].

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 addition of a substance to the [F38 domestic] list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the [F38 domestic] list, [F39 may be prescribed by the appropriate authority after seeking advice from the Authority].

F40 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F32 Word in Art. 7 heading 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, 44; 2020 c. 1, Sch. 5 para. 1(1)

F33 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)

F34 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)

F35 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)

F36 Word in Art. 7(4) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 15

F37 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)

F38 Word 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)(i); 2020 c. 1, Sch. 5 para. 1(1)

F39 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)

F40 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)

Article 8 U.K. Additional information concerning risk management

1. Where the [F41 Authority] 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. F42 ...

2. If the additional information is not sent within the additional period referred to in paragraph 1, the [F43 Authority] shall act on the basis of the information already provided.

Textual Amendments

F41 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)

F42 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)

F43 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)

CHAPTER III U.K. MISCELLANEOUS PROVISIONS

Article 9 U.K. Implementing measures

1. F44 ... The implementing measures for this Regulation [F45 may be prescribed by the appropriate authority after seeking advice from the Authority], 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.

F46 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F44 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)

F45 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)

F46 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)

Article 10 U.K. Extension of time periods

In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the [F47 Authority] on its own initiative F48 ..., if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases the [F47 Authority] shall, where appropriate, inform the applicant F49 ... of the extension and the reasons for it.

Textual Amendments

F47 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)

F48 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)

F49 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)

Article 11 U.K. Transparency

The Authority [F50 must] 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).

Textual Amendments

F50 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)

Article 12 U.K. 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. The [F51 Authority] shall decide after consulting with the applicants which information can remain confidential and shall notify applicants F52 ... accordingly.

4. After being made aware of the [F53 Authority's] 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.

F54 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. If an applicant withdraws, or has withdrawn, its application, the [F55 appropriate authority and the Authority] shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the [F56 Authority] and the applicant.

7. The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the [F57 appropriate authority and the Authority].

Textual Amendments

F51 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)

F52 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)

F53 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)

F54 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)

F55 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)

F56 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)

F57 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)

F58 Article 13 U.K. Emergencies

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Textual Amendments

F58 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)

F59 Article 14 U.K. Committee

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Textual Amendments

F59 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)

[F60 Article 14A U.K. 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.]

Textual Amendments

F60 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)

F61 Article 15 U.K. Competent authorities of the Member States

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Textual Amendments

F61 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)

CHAPTER IV U.K. FINAL PROVISION

Article 16 U.K. 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.

F62 ...

Done at Strasbourg, 16 December 2008.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

B. Le Maire

Textual Amendments

F62 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)

(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.