http://www.legislation.gov.uk/eur/2009/450/chapter/IICommission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (Text with EEA relevance)Commission Regulation (EC) No 450/2009Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R0450texttext/xmlen2025-05-27Expert Participation2025-04-01 CHAPTER II<Strong>COMPOSITION</Strong>SECTION 1<Strong><Emphasis><Substitution ChangeId="key-27c93c9c202eeb1ff918702158a3fc05-1747901771505" CommentaryRef="key-27c93c9c202eeb1ff918702158a3fc05">Authorised substances</Substitution></Emphasis></Strong><Substitution ChangeId="key-c331b2f204e1ea10af85278bc78fac98-1747900647000" CommentaryRef="key-c331b2f204e1ea10af85278bc78fac98">Requirement for authorisation</Substitution>Article 51Only substances that are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) No 1935/2004 may be used in components of active and intelligent materials and articles.2By way of derogation from paragraph 1, the following substances may be used in components of active and intelligent materials and articles without being authorised:areleased active substances provided that they comply with the conditions set out in Article 9;bsubstances falling within the scope of assimilated law or any other enactment provisions applicable to food, which are added to or incorporated into active materials and articles by techniques such as grafting or immobilisation in order to have a technological effect in the food, provided that they comply with the conditions set out in Article 9;csubstances used in components which are not in direct contact with food or the environment surrounding the food and are separated from the food by a functional barrier provided that they comply with the conditions set out in Article 10 and that they do not fall within either of the following categories:substances classified as ‘mutagenic’, ‘carcinogenic’, or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6 and 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council;substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale.Conditions for <Substitution ChangeId="key-e08b54b72fbd5c831dd60e7ced0f9a78-1747900715000" CommentaryRef="key-e08b54b72fbd5c831dd60e7ced0f9a78">authorisation</Substitution>Article 6In order to be authorised, substances which constitute the components of active and intelligent materials and articles must satisfy the requirements of Article 3 and, where they apply, Article 4 of Regulation (EC) No 1935/2004 for the intended condition of use of the active or intelligent material or article.Content of <Substitution ChangeId="key-f8f748635910e2e73b16b21144b8d00c-1747901265000" CommentaryRef="key-f8f748635910e2e73b16b21144b8d00c">an authorisation</Substitution>Article 7An authorisation shall specify:the identity of the substance(s);the function of the substance(s);the reference number;if necessary, the conditions of use of the substance(s) or component;if necessary, restrictions and/or specifications of use of the substance(s);if necessary, conditions of use of the material or article to which the substance or component is added or into which it is incorporated.Conditions for the establishment of the listArticle 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .<Addition ChangeId="key-f6d23996b3a23304a9f40698ef853f8e-1747901336000" CommentaryRef="key-f6d23996b3a23304a9f40698ef853f8e">Registered substances</Addition>Article 8A1The Food Safety Authority may ask a person (“the applicant”) who applied for a registered substance to be entered in the Register to provide, within a specified period, such supplementary information or additional data as the Food Safety Authority considers necessary to evaluate that substance for the purpose of delivering its opinion to the appropriate authority prior to the determination of the authorisation status of that substance.2The Food Safety Authority may extend the period of time described in paragraph 1.3Where the Food Safety Authority makes a request under paragraph 1 and the applicant fails to provide the information or data requested within the specified period (including any extension of that period), the substance shall cease to be treated as a registered substance after the end of the day on which the applicant was required to provide the requested information but failed to do so.4Before determining the authorisation status of all registered substances (which, under Article 14, would cause Article 4(e) and 5 to begin to apply), the appropriate authority must:ahave regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; andbconsider the time that may reasonably be needed by a person to apply for an unregistered substance to be authorised in accordance with Regulation (EC) No 1935/2004 and this Regulation.<Addition ChangeId="key-f6d23996b3a23304a9f40698ef853f8e-1747901336000" CommentaryRef="key-f6d23996b3a23304a9f40698ef853f8e">Determination of authorisation status: registered substances</Addition>Article 8B1For the purposes of Article 8A, determining the authorisation status of a registered substance is to consist of the appropriate authority determining whether the registered substance is:ato be authorised for placing on the market or for use in contact with food;bto cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance.2A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which:aexisting stocks of the registered substance concerned, and any products derived from it or containing it, may be placed on the market or used;bthe registered substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;cthe labelling of the registered substance concerned, and any products derived from it or containing it, may continue to be applied.3Where the appropriate authority makes a determination as to the authorisation status of a registered substance, the appropriate authority must:ain the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; andbcommunicate the determination to the Food Safety Authority.SECTION 2<Strong><Emphasis>Conditions of use for substances <Substitution ChangeId="key-8453b4baa1c0b54fa57355e3458210f4-1747901716257" CommentaryRef="key-8453b4baa1c0b54fa57355e3458210f4">referred to in Article 5(2)</Substitution> </Emphasis></Strong>Substances referred to in Article 5(2)(a) and (b)Article 91Released active substances, as referred to in Article 5(2)(a) of this Regulation and substances added or incorporated by techniques such as grafting or immobilisation, as referred to in Article 5(2)(b) of this Regulation, shall be used in full compliance with assimilated law and any other enactment applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and, when applicable, its implementing measures.2The amount of a released active substance shall not be included in the value of the measured overall migration, in cases where an overall migration limit (OML) is established in a specific ... measure for the food contact material in which the component is incorporated.3Without prejudice to Article 4(1) and (3) of Regulation (EC) No 1935/2004, the amount of a released active substance may exceed the specific restriction established for that substance in assimilated law or any other enactment relating to the food contact materials in which the component is incorporated provided it complies with the assimilated law applicable to food, or, where no such provisions exist, with the national provisions applicable to food.Substances referred to in Article 5(2)(c)Article 101The migration into food of the substances from components which are not in direct contact with food or the environment surrounding the food, as referred to in Article 5(2)(c) of this Regulation, shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council.2The limit provided for in paragraph 1 shall always be expressed as a concentration in foods. It shall apply to a group of substances, if they are structurally and toxicologically related, in particular isomers or substances with the same relevant functional group, and shall include possible set-off transfer. OJ L 353, 31.12.2008, p. 1. OJ L 165, 30.4.2004, p. 1. Words in Art. 5(2)(b) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 56(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 9(1) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 61(a); 2020 c. 1, Sch. 5 para. 1(1)Word in Art. 9(2) omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 61(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 9(3) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 61(c)(i); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 9(3) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 61(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)Word in Art. 5(2)(b) 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. 17(a)Word in Art. 9 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. 17(b)Art. 5 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), 12(4)(a) (with reg. 23)Art. 5(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), 12(4)(b) (with reg. 23)Word in Art. 5(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), 12(4)(c) (with reg. 23)Word in Art. 6 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), 12(5)(a) (with reg. 23)Word in Art. 6 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), 12(5)(b) (with reg. 23)Words in 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), 12(6)(a) (with reg. 23)Words in Art. 7 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), 12(6)(b) (with reg. 23)Arts. 8A, 8B substituted for Art. 8 (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), 12(7) (with reg. 23)Words in Section 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), 12(8) (with reg. 23)Section 1 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), 12(3) (with reg. 23)