
CHAPTER I
Article 1 
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 ... provisions applicable to the materials and articles to which active or intelligent components are added or into which they are incorporated.
Article 2 
This Regulation shall apply to active and intelligent materials and articles which are placed on the market ....
Article 3 
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;
((g)) ‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004;
((h)) ‘registered substance’ means a substance that was entered in the Register immediately before IP completion day;
((i)) ‘Register’ means the “Register of substances for which a valid application for authorisation was submitted under Regulation (EC) No 450/2009” published by the European Commission, dated 14 June 2012, version 1.1, as it had effect in the European Union immediately before IP completion day.
Article 4 
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
SECTION 1
Article 5 

1. Only 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.
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 authorised:
(a) released active substances provided that they comply with the conditions set out in Article 9;
(b) substances 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;
(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;
((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 
In 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.
Article 7 
An authorisation 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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 8A 

(1. The 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.
(2. The Food Safety Authority may extend the period of time described in paragraph 1.
(3. Where 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.
(4. Before 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:
(a) have regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; and
(b) consider 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.
Article 8B 

(1. For 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:
(a) to be authorised for placing on the market or for use in contact with food;
(b) to cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance.
(2. A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which:
(a) existing stocks of the registered substance concerned, and any products derived from it or containing it, may be placed on the market or used;
(b) the registered substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;
(c) the labelling of the registered substance concerned, and any products derived from it or containing it, may continue to be applied.
(3. Where the appropriate authority makes a determination as to the authorisation status of a registered substance, the appropriate authority must:
(a) in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and
(b) communicate the determination to the Food Safety Authority.
SECTION 2
Article 9 

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   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.
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 ... 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   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.
Article 10 

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.
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
Article 11 

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, with the words ‘DO NOT EAT’.
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 2 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, etc.,  and shall be subject to the provisions of  that Regulation.
CHAPTER IV
Article 12 

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 
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 ... 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
Article 14 
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 that the appropriate authority determines the authorisation status of all registered substances in the Register pursuant to Article 8A and 8B. 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 described in the second paragraph of this Article, registered substances and other released active substances shall be permitted to be placed on the market and used in accordance with the relevant ... provisions applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and its implementing measures.
...Done at Brussels, 29 May 2009.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX I

ANNEX II

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 ... measures applicable;
6.. adequate information relative to the substances which constitute the components, for which restrictions are in place under   assimilated  law or any other enactment  applicable to food and this Regulation; where appropriate, specific purity criteria in accordance with the relevant ... 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.
