30.5.2009 EN Official Journal of the European Union L 135/3 COMMISSION 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) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(1) (h), (i), (l), (m) and (n) thereof, After consulting the European Food Safety Authority, Whereas: (1) Regulation (EC) No 1935/2004 establishes that active and intelligent food contact materials and articles (active and intelligent materials and articles) are included in its field of application and, therefore, all its provisions concerning materials and articles intended to come into contact with food (food contact materials) also apply to these materials and articles. Other Community measures, such as those provided for in Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (2) and its implementing measures, and Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of the consumers (3), also apply, where appropriate, to such materials and articles. (2) Regulation (EC) No 1935/2004 lays down the general principles for eliminating the differences between the laws of the Member States as regards food contact materials. Article 5(1) of that Regulation provides for the adoption of specific measures for groups of materials and articles and describes in detail the procedure for the authorisation of substances at Community level when a specific measure provides for a list of authorised substances. (3) Certain rules applicable to active and intelligent materials and articles are set out in Regulation (EC) No 1935/2004. These include rules for released active substances that have to comply with Community and national provisions applicable to food and labelling rules. Specific rules should be laid down in a specific measure. (4) This Regulation is a specific measure within the meaning of Article 5(1)(b) of Regulation (EC) No 1935/2004. This Regulation should establish the specific rules for active and intelligent materials and articles to be applied in addition to the general requirements established in Regulation (EC) No 1935/2004 for their safe use. (5) Many different types of active and intelligent materials and articles exist. The substances responsible for the active and/or intelligent function can be contained in a separate container, for example, inclusion in a small paper sachet or, the substances can be directly incorporated into the packaging material, for example, incorporation in the plastic of a plastic bottle. Those substances, responsible for creating the active and/or intelligent function of those materials and articles (the components) should be evaluated in accordance with this Regulation. The passive parts, such as the container, the packaging into which that container is placed and the packaging material, in which the substance is incorporated, should be covered by the specific Community or national provisions applicable to those materials and articles. (6) The active and intelligent materials and articles may be composed of one or more layers, or parts of different types of materials, such as plastics, paper and cardboard or coatings and varnishes. Requirements for those materials may be either fully harmonised, or only partially harmonised, or not yet harmonised at Community level. The rules laid down in this Regulation should apply without prejudice to Community or national provisions that regulate such materials. (7) The individual substance or, if relevant, the combination of substances which constitute the components should be evaluated to guarantee that they are safe and comply with the requirements laid down in Regulation (EC) No 1935/2004. In some cases, it may be necessary to evaluate and authorise the combination of substances, when the active or intelligent function implies interaction between different substances leading to an enhancement of the function or the generation of new substances responsible for the active and intelligent function. (8) Regulation (EC) No 1935/2004 provides that when specific measures include a list of substances authorised within the Community for use in the manufacture of materials and articles intended to come into contact with food, those substances should undergo a safety assessment prior to their authorisation. (9) It is appropriate that the person interested in placing on the market active and intelligent materials and articles or the components thereof, namely the applicant, should submit all the information necessary for the safety assessment of the substance or, if necessary, of the combination of substances which constitutes the component. (10) The safety assessment of a substance or of a combination of substances which constitutes the components should be carried out by the European Food Safety Authority (the Authority), after the submission of a valid application, in accordance with Articles 9 and 10 of Regulation (EC) No 1935/2004. In order to inform the applicant of the data to be provided for the safety assessment, the Authority should publish detailed guidelines concerning the preparation and the submission of the application. In order to enable the enforcement of any possible restrictions, it is necessary that the applicant provides an appropriate analytical method for the detection and quantification of the substance. The Authority should evaluate if the analytical method is suitable for the purpose of enforcement of any proposed restriction. (11) The safety assessment of a specific substance or of a combination of substances should be followed by a risk management decision as to whether the substance should be included in the Community list of authorised substances that may be used in active and intelligent components (the Community list). That decision should be adopted in accordance with the regulatory procedure referred to in Article 23(2) of Regulation (EC) No 1935/2004 ensuring close cooperation between the Commission and the Member States. (12) The Community list should include the identity, conditions of use, restrictions and/or specifications of use of the substance or of a combination of substances and, where necessary, of the component or of the material or of the article in which they are added to or incorporated into. The identity of a substance should include at least the name and, if available and necessary, the CAS numbers, particle size, composition or other specifications. (13) Active materials and articles may deliberately incorporate substances, which are intended to be released into food. As these substances are intentionally added to the food, they should only be used under the conditions set out in the relevant Community or national provisions for their use in food. Where the Community or national provisions provide for an authorisation of the substance, the substance and its use should comply with the requirements of the authorisation under the specific legislation on food, such as legislation on food additives. Food additives and enzymes could also be grafted or immobilised on the material and have a technological function on the food. Such applications are covered by legislation on food additives and enzymes and should, therefore, be treated in the same way as released active substances. (14) Intelligent packaging systems provide the user with information on the conditions of the food and should not release their constituents into the food. Intelligent systems may be positioned on the outer surface of the package and may be separated from the food by a functional barrier, which is a barrier within food contact materials or articles preventing the migration of substances from behind that barrier into the food. Behind a functional barrier, non-authorised substances may be used, provided they fulfil certain criteria and their migration remains below a given detection limit. Taking into account foods for infants and other particularly susceptible persons, as well as the difficulties of this type of analysis affected by a large analytical tolerance, a maximum level of 0,01 mg/kg in food should be established for the migration of a non-authorised substance through a functional barrier. New technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. Therefore, they should not be covered by the functional barrier concept. (15) The specific Community measure covering the passive part of an active or intelligent material may lay down requirements for the inertness of the material, for example, an overall migration limit applicable to plastic materials. If a releasing active component is incorporated into a food contact material covered by a specific Community measure, there may be a risk of exceeding the overall migration limit due to the release of the active substance. As the active function is not an inherent feature of the passive material, the amount of released active substance should not be calculated in the value of overall migration. (16) Article 4(5) of Regulation (EC) No 1935/2004 provides that active and intelligent materials and articles already brought into contact with food are to be adequately labelled to allow identification by the consumer of non-edible parts. Consistency of such information is indispensable in order to avoid confusion at consumer level. Therefore, active and intelligent materials and articles should be labelled with appropriate words and accompanied, where technically possible, by a symbol, whenever materials and articles or parts of them are perceived as edible. (17) Article 16 of Regulation (EC) No 1935/2004 provides that materials and articles are to be accompanied by a written declaration of compliance attesting that they comply with the rules applicable to them. In accordance with Article 5(1)(h) and (i) of that Regulation, to strengthen the coordination and responsibility of the suppliers at each stage of the manufacturing process, the responsible persons should document compliance with the relevant rules in a declaration of compliance which is made available to his customer. In addition, at each stage of the manufacturing process, supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities. (18) Article 17(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4) requires food business operators to verify that foods satisfy the relevant requirements of food law. Article 15(1)(e) of Regulation (EC) No 1935/2004 provides that active materials and articles, which are not yet in contact with food when placed on the market, are to be accompanied by information on the permitted use or uses and other relevant information such as the name and maximum quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labelling. To this end, subject to the requirement of confidentiality, food business operators should be given access to the relevant information to enable them to ensure that the migration or intentional release from active and intelligent materials and articles to food complies with the specifications and restrictions laid down in Community or national provisions applicable to food. (19) Since several active and intelligent materials and articles are already on the market in the Member States, provisions should be established to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing market for those materials and articles. Sufficient time should be allowed for the applicant to make available the information necessary for the safety assessment of the substance or the combination of substances which constitutes the component. Therefore, an 18 month period should be allowed, during which time the information on active and intelligent materials and articles should be submitted by the applicants. It should also be possible to submit applications for authorisation of a new substance or of a combination of substances during that 18 month period. (20) The Authority should evaluate, without delay, all applications for existing as well as new substances which constitute the components for which a valid application was submitted on time and in accordance with the guidelines of the Authority during the initial application phase. (21) A Community list of authorised substances should be drawn up by the Commission after the completion of the safety assessment of all substances for which a valid application was submitted in accordance with the guidelines of the Authority, during the initial 18 month period. In order to ensure fair and equal conditions for all applicants, this Community list should be drawn up in a single step. (22) The rules concerning the declaration of compliance and the specific labelling rules should only apply six months after the date of entry into force of this Regulation to give business operators sufficient time to adapt to these new rules. (23) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes specific requirements for the marketing of active and intelligent materials and articles intended to come into contact with food. These specific requirements are without prejudice to Community or national provisions applicable to the materials and articles to which active or intelligent components are added or into which they are incorporated. Article 2 Scope This Regulation shall apply to active and intelligent materials and articles which are placed on the market within the Community. Article 3 Definitions For the purpose of this Regulation, the following definitions shall apply: (a) ‘active materials and articles’ means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food; (b) ‘intelligent materials and articles’ means materials and articles which monitor the condition of packaged food or the environment surrounding the food; (c) ‘component’ means an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into; (d) ‘functional barrier’ means a barrier consisting of one or more layers of food contact materials which ensures that the finished material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with this Regulation; (e) ‘releasing active materials and articles’ are those active materials and articles designed to deliberately incorporate components that would release substances into or onto the packaged food or the environment surrounding the food; (f) ‘released active substances’ are those substances intended to be released from releasing active materials and articles into or onto the packaged food or the environment surrounding the food and fulfilling a purpose in the food. Article 4 Placing on the market of active and intelligent materials and articles Active and intelligent materials and articles may only be placed on the market if they: (a) are suitable and effective for the intended purpose of use; (b) comply with the general requirements set out in Article 3 of Regulation (EC) No 1935/2004; (c) comply with the special requirements set out in Article 4 of Regulation (EC) No 1935/2004; (d) comply with the labelling requirements set out in Article 15(1)(e) of Regulation (EC) No 1935/2004; (e) comply with the composition requirements set out in Chapter II of this Regulation; (f) comply with labelling and declaration requirements set out in Chapters III and IV of this Regulation. CHAPTER II COMPOSITION SECTION 1 Community list of authorised substances Article 5 Community list of substances that may be used in active and intelligent components 1. Only substances which are included in the ‘Community list’ of authorised substances (hereinafter referred to as the Community list) may be used in components of active and intelligent materials and articles. 2. By way of derogation from paragraph 1, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list: (a) released active substances provided that they comply with the conditions set out in Article 9; (b) substances falling within the scope of Community or national 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; (c) substances 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: (i) 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 (5); (ii) substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale. Article 6 Conditions for inclusion of substances in the Community list In order to be included in the Community list, 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. Article 7 Content of the Community list The Community list shall specify: (a) the identity of the substance(s); (b) the function of the substance(s); (c) the reference number; (d) if necessary, the conditions of use of the substance(s) or component; (e) if necessary, restrictions and/or specifications of use of the substance(s); (f) if necessary, conditions of use of the material or article to which the substance or component is added or into which it is incorporated. Article 8 Conditions for the establishment of the Community list 1. The Community list shall be drawn up on the basis of applications made pursuant to Article 9 of Regulation (EC) No 1935/2004. 2. The deadline for submitting applications shall be 18 months following the date of publication of the guidelines of the European Food Safety Authority (the Authority) for the safety assessment of substances used in active and intelligent materials and articles. The Authority shall publish those guidelines at the latest six months after the date of publication of this Regulation. 3. The Commission shall make available to the public a register which contains all substances for which a valid application has been submitted in accordance with paragraph 2. 4. The Community list shall be adopted by the Commission in accordance with the procedure laid down in Articles 10 and 11 of Regulation (EC) No 1935/2004. 5. Where the Authority requests supplementary information and the applicant fails to provide the additional data within the set time limit, the substance shall not be evaluated by the Authority for inclusion in the Community list as the application cannot be considered a valid application. 6. The Commission shall adopt the Community list after the Authority has delivered its opinion on all substances included in the register for which a valid application has been submitted pursuant to paragraphs 2 and 5. 7. For the addition of new substances to the Community list, the procedure laid down in Articles 9, 10 and 11 of Regulation (EC) No 1935/2004 shall apply. SECTION 2 Conditions of use for substances not to be included in the Community list Article 9 Substances referred to in Article 5(2)(a) and (b) 1. Released 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 the relevant Community and national provisions applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and, when applicable, its implementing measures. 2. The 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 Community measure for the food contact material in which the component is incorporated. 3. Without 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 a specific Community or national measure on the food contact materials in which the component is incorporated provided it complies with the Community provisions applicable to food, or, where no such provisions exist, with the national provisions applicable to food. Article 10 Substances referred to in Article 5(2)(c) 1. The 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 (6). 2. The 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. CHAPTER III LABELLING Article 11 Additional rules on labelling 1. To allow identification by the consumer of non-edible parts, active and intelligent materials and articles or parts thereof shall be labelled, whenever they are perceived as edible: (a) with the words ‘DO NOT EAT’; and (b) always where technically possible, with the symbol reproduced in Annex I. 2. The information required by paragraph 1 shall be conspicuous, clearly legible and indelible. It shall be printed in characters of a font size of at least 3 mm and comply with the requirements set out in Article 15 of Regulation (EC) No 1935/2004. 3. Released active substance shall be considered as ingredients within the meaning of Article 6(4)(a) of Directive 2000/13/EC of the European Parliament and of the Council (7) and shall be subject to the provisions of that Directive. CHAPTER IV DECLARATION OF COMPLIANCE AND DOCUMENTATION Article 12 Declaration of compliance 1. At the marketing stages other than at the point of sale to the final consumer, active and intelligent materials and articles, whether or not they are in contact with food, or the components intended for the manufacturing of those materials and articles or the substances intended for the manufacturing of those components, shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. 2. The declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information set out in Annex II. Article 13 Supporting documentation Appropriate documentation to demonstrate that the active and intelligent materials and articles and the components intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request. That documentation shall contain information on the suitability and effectiveness of the active or intelligent material or article, the conditions and results of testing or calculations or other analysis, and evidence on the safety or the reasoning demonstrating compliance. CHAPTER V FINAL PROVISIONS Article 14 Entry into force and application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4(e), and Article 5 shall apply from the date of application of the Community list. Until that date, and without prejudice to the requirements set out in Article 4(2) of Regulation (EC) No 1935/2004 and Articles 9 and 10 of this Regulation, national provisions in force concerning the composition of active and intelligent materials and articles shall continue to apply. Article 4(f), Article 11(1) and (2) and Chapter IV shall apply from 19 December 2009. Until that date, and without prejudice to the requirements set out in Article 4(5) and (6) of Regulation (EC) No 1935/2004 and Article 11(3) of this Regulation, national provisions in force concerning the labelling and declaration of compliance of active and intelligent materials and articles shall continue to apply. The placing on the market of active and intelligent materials and articles labelled in accordance with Article 4(5) of Regulation (EC) No 1935/2004 prior to the date of application of Article 11(1) and (2) of this Regulation shall be permitted until the exhaustion of stocks. Until the date of application of the Community list, released active substances shall be authorised and used in accordance with the relevant Community provisions applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and its implementing measures. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 May 2009. For the Commission Androulla VASSILIOU Member of the Commission (1) OJ L 338, 13.11.2004, p. 4. (2) OJ L 11, 15.1.2002, p. 4. (3) OJ L 192, 11.7.1987, p. 49. (4) OJ L 31, 1.2.2002, p. 1. (5) OJ L 353, 31.12.2008, p. 1. (6) OJ L 165, 30.4.2004, p. 1. (7) OJ L 109, 6.5.2000, p. 29. ANNEX I SYMBOL ANNEX II DECLARATION OF COMPLIANCE The written declaration referred to in Article 12 shall contain the following information: 1. the identity and address of the business operator which issues the declaration of compliance; 2. the identity and address of the business operator which manufactures or imports the active and intelligent materials and articles, or the components intended for the manufacturing of those materials and articles, or the substances intended for the manufacturing of the components; 3. the identity of the active and intelligent materials and articles or the components intended for the manufacturing of those materials and articles, or the substances intended for the manufacturing of the components; 4. the date of the declaration; 5. the confirmation that the active or intelligent material or article complies with the relevant requirements laid down in this Regulation, Regulation (EC) No 1935/2004, and in specific Community measures applicable; 6. adequate information relative to the substances which constitute the components, for which restrictions are in place under the Community or national provisions applicable to food and this Regulation; where appropriate, specific purity criteria in accordance with the relevant Community legislation applicable to food and, the name and quantity of the substances released by the active component, to allow the downstream business operators to ensure compliance with those restrictions; 7. adequate information on the suitability and effectiveness of the active or intelligent material or article; 8. specifications on the use of the component, such as: (i) the group or groups of materials and articles in which the component may be added to or incorporated into; (ii) the conditions of use necessary to achieving the intended effect; 9. specifications on the use of the material or article, such as: (i) the type or types of food intended to be put in contact with it; (ii) the time and temperature of treatment and storage in contact with the food; (iii) the ratio of food contact surface area to volume used to establish the compliance of the material or article; 10. when a functional barrier is used, the confirmation that the active or intelligent material or article complies with Article 10 of this Regulation. The written declaration shall permit an easy identification of the active and intelligent materials and articles or the component or the substance for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration or when new scientific data are available.

Summary: Active and intelligent materials and articles that come into contact with food Active and intelligent materials and articles that come into contact with food SUMMARY OF: Regulation (EC) No 450/2009 — active and intelligent materials and articles intended to come into contact with food WHAT IS THE AIM OF THE REGULATION? It seeks to lay down specific rules for active* and intelligent* materials and articles, which supplement those set out in Regulation (EC) No 1935/2004, the general regulation on materials and articles intended to come into contact with food. It establishes specific requirements for the marketing of these materials and articles and sets out the procedure for their authorisation at EU level. KEY POINTS Scope The regulation applies to active or intelligent materials and articles intended to come into contact with food which are placed on the EU market. Requirements for active and intelligent materials and articles Active and intelligent materials and articles: must be suitable and effective for the intended purpose of use; must not release into the food any components* in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition, taste or smell of food; must not mislead consumers through their labelling, presentation or advertising material. These specific requirements are without prejudice to EU or national rules applicable to materials and articles to which active or intelligent components are added or into which they are incorporated. Those materials may be subject to other specific legislation, such as Regulation (EU) No 10/2011 on plastic food contact materials. Composition Once the regulation enters fully into force, only substances which are included in the Union list of authorised substances may be used in components of active and intelligent materials and articles. It will enter fully into force after the European Commission publishes a list of substances that may be used in the manufacture of active and intelligent components. The following substances may be used in components of active and intelligent materials and articles without being included in the list: released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant EU and national rules (for example, legislation on food additives and food enzymes);substances used in the 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, and if they are not mutagenic, carcinogenic, or toxic to reproduction or substances produced deliberately in a particle size that exhibits chemical and physical properties that significantly differ from those at a larger scale. Applications for authorisation of substances constituting the components of active and intelligent materials and articles Applications for authorisation of substances constituting the components of active and intelligent materials and articles are to be made to the competent authorities of an EU country accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority (EFSA). The EU country sends the application to EFSA which is responsible for assessing whether the substance meets the above conditions. Union list of authorised substances To be included in the Union list, substances constituting the components of active and intelligent materials and articles must meet the requirements that apply to the said products (see above). The Commission must adopt the Union list after EFSA has delivered its opinion on all substances for which a valid application for market authorisation has been submitted. The Union list specifies: 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. Labelling Active and intelligent materials and articles: in contact with food are to be labelled appropriately to allow the consumer to identify the non-edible parts. In this case the words ‘DO NOT EAT’ must be added to the label as well as (if possible) the symbol reproduced in Annex I; must be labelled so that it is clear that they are active and/or intelligent. Released active substances are considered as ingredients and must be labelled according to Regulation (EU) No 1169/2011 on the labelling of foodstuffs. Packaging It should also be noted that Regulation (EC) No 1935/2004 on the safe packaging of foods contains some rules directly applicable to active and intelligent materials, including definitions and labelling requirements. It authorises the use of active and intelligent packaging, which can extend the shelf-life of food and give information on its freshness, provided that the packaging does not adversely affect its composition. Declaration of compliance Businesses must issue at marketing stages other than at the point of sale to the final consumer, a written declaration of compliance containing the information set out in Annex II to the regulation, whether or not the active and intelligent materials and articles are in contact with food. This declaration must also be issued for the components intended for the manufacturing of those materials and articles or the substances intended for the manufacturing of those components. FROM WHEN DOES THE REGULATION APPLY? It has applied since 19 December 2009. BACKGROUND For more information, see: Active and intelligent packaging substances (EFSA) Food contact materials (European Commission) EU Guidance to the Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (European Commission). KEY TERMS Active materials and articles: materials and articles intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release substances into or onto the packaged food or the environment surrounding the food. Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food. A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into. MAIN DOCUMENT Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (OJ L 135, 30.5.2009, pp. 3-11) RELATED DOCUMENTS Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18-63) Successive amendments to Regulation (EU) No 1169/2011 have been incorporated into the original document. This consolidated version is of documentary value only. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, pp. 1-89) See consolidated version. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, pp. 4-17) See consolidated version. last update 11.07.2019


15.5.2009 EN Official Journal of the European Union L 120/22 COMMISSION RECOMMENDATION of 30 April 2009 on remuneration policies in the financial services sector (Text with EEA relevance) (2009/384/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular the second indent of Article 211 thereof, Whereas: (1) Excessive risk-taking in the financial services industry and in particular in banks and investment firms has contributed to the failure of financial undertakings and to systemic problems in the Member States and globally. These problems have spread to the rest of the economy and led to high costs for society. (2) Whilst not the main cause of the financial crisis that unfolded in 2007 and 2008, there is a widespread consensus that inappropriate remuneration practices in the financial services industry also induced excessive risk-taking and thus contributed to significant losses of major financial undertakings. (3) Remuneration practices in a large part of the financial services industry have been running counter to effective and sound risk management. These practices tended to reward short-term profit and gave staff incentives to pursue unduly risky activities which provided higher income in the short term while exposing financial undertakings to higher potential losses in the longer term. (4) In principle, if risk management and control systems were strong and highly effective, the risk-taking incentives provided by remuneration practices would be consistent with the risk tolerance of a financial undertaking. However, all risk management and control systems have limitations and, as the financial crisis has shown, can fail to deal with the risks created by inappropriate incentives, due to the increasing complexity of the risks and the range of ways by which risk may be taken. Consequently, a simple functional separation between business units and staff responsible for risk management and control systems is necessary but no longer sufficient. (5) Creating appropriate incentives within the remuneration system itself should reduce the burden on risk management and increase the likelihood that these systems become effective. Therefore, there is a need to establish principles on sound remuneration policies. (6) Given the competitive pressures in the financial services industry and the fact that many financial undertakings operate cross-border, it is important to ensure that principles on sound remuneration policy are applied consistently throughout the Member States. However, it is acknowledged that to be more effective, principles on sound remuneration policy would need to be implemented globally and in a consistent manner. (7) In its Communication to the Spring European Council ‘Driving European Recovery’ (1), the Commission presented its plan to restore and maintain a stable and reliable financial system. In particular, the Communication announced that a new Recommendation on remuneration in the financial services sector would be presented in order to improve risk management in financial firms and align pay incentives with sustainable performance. (8) This Recommendation sets out general principles applicable to remuneration policy in the financial services sector and should apply to all financial undertakings operating in the financial services industry. (9) Those general principles may be of more relevance to certain categories of financial undertakings than others, in the light of existing regulations and common practices in the financial services industry. These principles should apply in parallel to any rule or regulation governing a specific financial sector. In particular, fees and commissions received by intermediaries and external service providers in case of outsourced activities should not be addressed, since the compensation practices relating to such fees and commissions are already partially covered by particular regimes, in particular Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (2) and Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation (3). Furthermore, this Recommendation is without prejudice to the rights, where applicable, of social partners in collective bargaining. (10) With respect to financial undertakings whose securities are admitted to trading on a regulated market within the meaning of Directive 2004/39/EC in one or more Member States, this Recommendation apply in addition to and together with Commission Recommendation 2004/913/EC of 14 December 2004 fostering an appropriate regime for the remuneration of directors of listed companies (4) and Commission Recommendation 2009/385/EC of 30 April 2009 complementing Recommendations 2004/913/EC and 2005/162/EC as regards the regime for the remuneration of directors of listed companies (5). (11) The remuneration policy of a particular financial undertaking should also be linked to the size of the financial undertaking concerned, as well as the nature and the complexity of its activities. (12) A risk-focused remuneration policy, which is consistent with effective risk management and does not entail excessive risk exposure, should be adopted. (13) Remuneration policy should cover those categories of staff whose professional activities have a material impact on the risk profile of the financial undertaking. In order to avoid incentives for excessive risk-taking, special arrangements should be adopted with regard to the remuneration of these categories of staff. (14) Remuneration policy should aim at aligning the personal objectives of staff members with the long-term interests of the financial undertaking concerned. The assessment of the performance-based components of remuneration should be based on longer-term performance and take into account the outstanding risks associated with the performance. The assessment of performance should be set in a multi-year framework, for example of three to five years, in order to ensure that the assessment process is based on longer term performance and that the actual payment of performance-based components of remuneration is spread over the business cycle of the company. (15) Financial undertakings should be able to reclaim variable components of remuneration that were awarded for performance based on data which has subsequently proven to be manifestly misstated. (16) As a general principle, payments related to early termination of a contract which are awarded on a contractual basis should not be a reward for failure. For directors of listed financial undertakings, specific provisions on termination payments set out in Recommendation 2009/385/EC should apply. (17) In order for remuneration policy to be in line with the objectives, the business strategy, the values and the long-term interests of the financial institution, other factors, apart from financial performance, should be considered, such as compliance with systems and controls of the financial institution, as well as compliance with the standards governing the relationship with clients and investors. (18) Effective governance is a necessary condition for the remuneration policy to be sound. The decision-making process regarding the remuneration policy of a financial undertaking should be internally transparent and should be designed in such a way as to avoid conflicts of interest and ensure the independence of the persons involved. (19) The governing body of the financial undertaking should have the ultimate responsibility for establishing the remuneration policy for the whole financial undertaking and monitoring its implementation. In order to provide necessary expertise, control functions and, where appropriate, human resources departments and experts should be involved in the process. In particular, control functions should also be involved in the design and the review of the implementation of the remuneration policy, and should be adequately rewarded so as to attract skilled individuals and to ensure their independence from the business units they control. The statutory auditor, within the limits of current reporting duties, should report on material weaknesses in the review of the implementation of the remuneration policy to the (supervisory) board or to the audit committee. (20) Control of the design and implementation of the remuneration policy is more likely to be effective if the stakeholders of the financial undertaking, including, where applicable, employee representatives, are properly informed of and engaged in the process of setting up and monitoring remuneration policy. For that purpose, financial undertakings should disclose the relevant information to their stakeholders. (21) The implementation of the principles laid down in this Recommendation should be reinforced through supervisory review at the national level. Therefore, supervisor’s overall assessment of the soundness of the financial undertaking should include the assessment of compliance of the remuneration policy of the financial undertaking with the principles laid down in this Recommendation. (22) Member States should ensure that branches of financial undertakings having their registered office or their head office in a third country and which operate in the territory of a Member State should be subject to similar principles on remuneration policy which apply to financial undertakings having their registered office or their head office in the territory of a Member State. (23) This Recommendation should apply without prejudice to measures which might be adopted by Member States with respect to remuneration policies of financial undertakings which benefit from State assistance. (24) The notification of measures by Member States in accordance with this Recommendation should include a clear timeframe for financial undertakings to adopt remuneration policies consistent with the principles set out in this Recommendation, HEREBY RECOMMENDS: SECTION I Scope and definitions 1. Scope 1.1. Member States should ensure that the principles contained in sections II, III and IV apply to all financial undertakings having their registered office or their head office in their territory. 1.2. Member States should ensure that the principles contained in sections II, III and IV apply to the remuneration of those categories of staff whose professional activities have a material impact on the risk profile of the financial undertaking. 1.3. When taking measures to ensure that financial undertakings implement those principles, Member States should take into account the nature, the size as well as the specific scope of activities of the financial undertakings concerned. 1.4. Member States should apply the principles contained in sections II, III and IV to financial undertakings on an individual basis and on a consolidated basis. Principles on sound remuneration policy should apply at group level to the parent undertaking and to its subsidiaries, including those established in offshore financial centres. 1.5. This Recommendation does not apply to fees and commissions received by intermediaries and external service providers in case of outsourced activities. 2. Definitions for the purposes of this Recommendation 2.1. ‘Financial undertaking’ means any undertaking, irrespective of its legal status, whether regulated or not, which performs any of the following activities on a professional basis: (a) it accepts deposits and other repayable funds; (b) it provides investment services and/or performs investment activities within the meaning of Directive 2004/39/EC; (c) it is involved in insurance or reinsurance business; (d) it performs business activities similar to those set out in points (a), (b) or (c). A financial undertaking includes, but is not limited to, credit institutions, investment firms, insurance and reinsurance undertakings, pension funds and collective investment schemes. 2.2. ‘Director’ means any member of the administrative, managerial or supervisory bodies of financial undertakings. 2.3. ‘Control functions’ means risk management, internal control and similar functions within a financial undertaking. 2.4. ‘Variable component of remuneration’ means a component of remuneration entitlement which is awarded on the basis of performance criteria, including bonuses. SECTION II Remuneration policy 3. General 3.1. Member States should ensure that financial undertakings establish, implement and maintain a remuneration policy which is consistent with and promotes sound and effective risk management and which does not induce excessive risk-taking. 3.2. Remuneration policy should be in line with the business strategy, objectives, values and long-term interests of the financial undertaking, such as sustainable growth prospects, and be consistent with the principles relating to the protection of clients and investors in the course of services provided. 4. Structure of the remuneration policy 4.1. Where remuneration includes a variable component or a bonus, remuneration policy should be structured with an appropriate balance of fixed and variable remuneration components. The appropriate balance of remuneration components may vary across staff members, according to market conditions and the specific context in which the financial undertaking operates. Member States should ensure that remuneration policy of a financial undertaking sets a maximum limit on the variable component. 4.2. The fixed component of the remuneration should represent a sufficiently high proportion of the total remuneration allowing the financial undertaking to operate a fully flexible bonus policy. In particular, the financial undertaking should be able to withhold bonuses entirely or partly when performance criteria are not met by the individual concerned, the business unit concerned or the financial undertaking. The financial undertaking should also be able to withhold bonuses where its situation deteriorates significantly, in particular where it can no longer be presumed that it can or will continue to be able to carry out its business as a going concern. 4.3. Where a significant bonus is awarded, the major part of the bonus should be deferred with a minimum deferment period. The amount of the deferred part of the bonus should be determined in relation to the total amount of the bonus as compared to the total amount of the remuneration. 4.4. The deferred element of the bonus should take into account the outstanding risks associated with the performance to which the bonus relates and may consist of equity, options, cash, or other funds the payment of which is postponed for the duration of the deferment period. The measures of future performance to which the deferred element is linked should be risk adjusted as set out in point 5. 4.5. Payments related to the early termination of a contract which are awarded on a contractual basis, should be related to performance achieved over time and designed in a way that does not reward failure. 4.6. Member States should ensure that the (supervisory) board of a financial undertaking can require staff members to repay all or part of bonuses that have been awarded for performance based on data which has subsequently proven to be manifestly misstated. 4.7. The structure of the remuneration policy should be updated over time to ensure that it evolves to meet the changing situation of the financial undertaking concerned. 5. Performance measurement 5.1. Where remuneration is performance related, its total amount should be based on a combination of the assessment of the performance of the individual and of the business unit concerned and of the overall results of the financial undertaking. 5.2. The assessment of performance should be set in a multi-year framework in order to ensure that the assessment process is based on longer term performance and that the actual payment of bonuses is spread over the business cycle of the company. 5.3. The measurement of performance, as a basis for bonus or bonus pools, should include an adjustment for current and future risks related to the underlying performance and should take into account the cost of the capital employed and the liquidity required. 5.4. When determining individual performance, non-financial criteria, such as compliance with internal rules and procedures, as well as compliance with the standards governing the relationship with clients and investors should be taken into account. 6. Governance 6.1. The remuneration policy should include measures to avoid conflicts of interest. The procedures for determining remuneration within the financial undertaking should be clear and documented and should be internally transparent. 6.2. The (supervisory) board should determine the remuneration of directors. In addition, the (supervisory) board should establish the general principles of the remuneration policy of the financial undertaking and be responsible for its implementation. 6.3. Control functions and, where appropriate, human resources departments and external experts should also be involved in the design of the remuneration policy. 6.4. Members of the (supervisory) board responsible for remuneration policy and members of the remuneration committees and staff members who are involved in the design and implementation of the remuneration policy should have relevant expertise and functional independence from the business units they control and thus be capable of forming an independent judgement on the suitability of the remuneration policy, including the implications for risk and risk management. 6.5. Without prejudice to the overall responsibility of the (supervisory) board as set out in point 6.2, the implementation of the remuneration policy should, at least on an annual basis, be subject to central and independent internal review by control functions for compliance with policies and procedures defined by the (supervisory) board. The control functions should report on the outcome of this review to the (supervisory) board. 6.6. Staff members engaged in control processes should be independent from the business units they oversee, have appropriate authority, and be compensated in accordance with the achievement of the objectives linked to their functions, independent of the performance of the business areas they control. In particular, with regard to insurance or reinsurance undertakings, the actuarial function and the responsible actuary should be remunerated in a manner commensurate with her or his role in the insurance or reinsurance undertaking and not in relation to the performance of the undertaking concerned. 6.7. The general principles of the remuneration policy should be accessible to staff members to whom they apply. Those staff members should be informed in advance of the criteria that will be used to determine their remuneration and of the appraisal process. The appraisal process and the remuneration policy should be properly documented and transparent to the individual staff members concerned. SECTION III Disclosure 7. Without prejudice to confidentiality and data protection provisions, relevant information on the remuneration policy referred to in section II and any updates in case of policy changes should be disclosed by the financial undertaking in a clear and easily understandable way to relevant stakeholders. Such disclosure may take the form of an independent remuneration policy statement, a periodic disclosure in annual financial statements or any other form. 8. The following information should be disclosed: (a) information concerning the decision-making process used for determining the remuneration policy, including if applicable, information about the composition and the mandate of a remuneration committee, the name of the external consultant whose services have been used for the determination of the remuneration policy and the role of the relevant stakeholders; (b) information on linkage between pay and performance; (c) information on the criteria used for performance measurement and the risk adjustment; (d) information on the performance criteria on which the entitlement to shares, options or variable components of remuneration is based; (e) the main parameters and rationale for any annual bonus scheme and any other non-cash benefits. 9. When determining the level of the information which should be disclosed, Member States should take into account the nature, the size as well as the specific scope of activities of the financial undertakings concerned. SECTION IV Supervision 10. Member States should ensure that competent authorities take into account the size of the financial undertaking and the nature and the complexity of its activities when monitoring whether the principles contained in sections II and III are followed. 11. Member States should ensure that financial undertakings are in a position to communicate the remuneration policy covered by this Recommendation to their competent authorities, including an indication of compliance with the principles set out in this Recommendation, in the form of a remuneration policy statement subject to appropriate updates. 12. Member States should ensure that competent authorities may request and have access to all information they need to evaluate the extent to which the principles contained in sections II and III are followed. SECTION V Final provisions 13. Member States are invited to take the necessary measures to promote the application of this Recommendation by 31 December 2009 and to notify the Commission of the measures taken in accordance with this Recommendation, in order to enable the Commission to monitor closely the situation and, on that basis, to assess the need for further measures. 14. This Recommendation is addressed to the Member States. Done at Brussels, 30 April 2009. For the Commission Siim KALLAS Vice-President (1) COM(2009) 114. (2) OJ L 145, 30.4.2004, p. 1. (3) OJ L 9, 15.1.2003, p. 3. (4) OJ L 385, 29.12.2004, p. 55. (5) See page 28 of this Official Journal.

Summary: Remuneration policies in the financial services sector Remuneration policies in the financial services sector SUMMARY OF: Recommendation 2009/384/EC — remuneration policies in the financial services sector WHAT IS THE AIM OF THE RECOMMENDATION? It aims to set out general principles applicable to remuneration practices in the financial services sector which aim at avoiding any excessive risk-taking in this sector, particularly by banks and investment firms. KEY POINTS The recommendation applies to: financial companies with their registered office or their head office in the territory of an EU country; remuneration of those categories of staff whose professional activities have a material impact on the risk profile of the company. The recommendation does not apply to fees and commissions received by intermediaries and external service providers in case of outsourced activities. Remuneration policy Remuneration policy should be in line with the business strategy, objectives, values and long-term interests of the financial company, such as sustainable growth prospects or the protection of clients and investors in the course of services provided. The remuneration policy should be the result of a balance between fixed and variable components. The fixed component should represent a sufficiently high proportion of the total remuneration allowing the undertaking to operate a fully flexible bonus policy. The structure of the remuneration policy should be updated regularly so that it corresponds to the development of the company. Where remuneration is performance-related, it should be evaluated according to current or future risks without omitting to take into account the cost of the capital employed and the liquidity required. The procedures followed should be clear, documented and internally transparent. The supervisory board should establish the general principles of the remuneration policy of the financial undertaking and be responsible for its implementation. Control functions, human resources departments and external experts should also be involved in the design of the remuneration policy. Remuneration policy should, at least annually, be subject to central and independent internal review by control functions for compliance with policies and procedures defined by the supervisory board. Disclosure Information on the remuneration policy should be disclosed by the undertaking in the form of an independent statement or a periodic disclosure and should list: information on the decision-making process which defines the remuneration policy chosen; information on the link between pay and performance; performance measurement criteria; the performance criteria on which the entitlement to shares, options or variable components of remuneration is based; the main parameters and rationale for any annual bonus scheme and any other non-cash benefits. Supervision The competent authorities should carry out supervisory activities, taking into account: the size of the company; the nature of its activities; the complexity of its activities. Financial companies should, in addition, send the competent authorities a statement indicating the level of compliance with the principles given above concerning remuneration policy. BACKGROUND Remuneration practices in the financial sector, particularly in banks and investment firms, have led to excessive risk-taking. These practices contributed, to a certain extent, to significant losses suffered by large financial undertakings and were partly responsible for the October 2008 financial crisis. The communication ‘Driving the European recovery’, published by the European Commission in spring 2009, presented a plan which aimed to restore and maintain a stable and reliable financial system. This recommendation on remuneration policies was part of the strategy proposed by the plan. MAIN DOCUMENT Commission Recommendation 2009/384/EC of 30 April 2009 on remuneration policies in the financial services sector (OJ L 120, 15.5.2009, pp. 22–27) RELATED DOCUMENTS Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, pp. 1–337) Successive amendments to Regulation (EU) No 575/2013 have been incorporated into the original document. This consolidated version is of documentary value only. Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, pp. 338–436) See consolidated version. Communication for the spring European Council — Driving European recovery `— Volume 1 (COM(2009) 114 final, 4.3.2009) last update 31.07.2018