EN    EN EN 
SANCO/2008/03261  EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 19.01.2009 
 
  
Draft 
COMMISSION REGULATION (EC) No  
of […] 
on active and intelligent materials and articl es intended to come into contact with food 
 
 EN 2   EN Draft 
COMMISSION REGULATION (EC) No  
of […] 
on active and intelligent materials and articl es intended to come into contact with food 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materi als and articles intended to come into contact with 
food1, and in particular Article 5(1) (i ), (h), (l), (m) and)(n) thereof, 
After consulting the European Food Sa fety Authority ("the Authority"), 
Whereas: (1) Regulation (EC) No 1935/2004
2 establishes that active and intelligent food contact 
materials and articles (active and intelligent materials and articles) are included in its field of application and, ther efore, all the provis ions provided for any type of materials 
and articles intended to come into contact with food (food contact mate rials) are also 
applicable to these materials. Similarl y, other provisions pr ovided for in other 
Community measures such as Directive 2001/95/EEC on general product safety
3 and 
its implementing measures, and Directive 87/357/EEC concerning products which, 
appearing to be other than they are, enda nger the health or safety of the consumers4 are 
also applicable, where appropr iate. The relevant provisions of all these Community 
measures are not repeated in this Regulation. 
(2) Regulation (EC) No 1935/2004 sets out the general principles for eliminating the 
differences between the laws of the Member States as regards food contact materials. 
That Regulation provides in Article 5(1) for the adoption of specific measures for 
groups of materials and articles and desc ribes 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 intellig ent materials and articles are set out in 
Regulation (EC) No 1935/2004.  These include provisions for released active 
substances that have to comply with Comm unity and national provi sions applicable to 
food and labelling rules. Specific rules s hould be laid down in a specific measure. 
                                                 
1 OJ L 338, 13.11.2004, p. 4. 
2  OJ L 338 of 13.11.2004, p.4. 
3  OJ L 11 of 15.1.2002, p.4. 
4  OJ L 192 of 25 June 1987, p.1  EN 3   EN (4) This Regulation is a specific measure with in the meaning of Article 5(1) (b) of 
Regulation (EC) No 1935/2004. This specific Re gulation should establish the specific 
rules for active and intelligent materials and articles to be applied in addition to the general requirements established in Regula tion (EC) No 1935/2004 for their safe use. 
(5) Many different types of active and intellig ent materials and articles exist. The 
substances responsible for the active and/or intelligent function can  be contained in a 
separate container e.g. inclus ion in a small paper sachet or, the substances can be 
directly incorporated in the packaging material e.g. incorporation in the plastic of a 
plastic bottle. Those substances, responsible  for creating the activ e and/or intelligent 
function of that material (the components ) should be evaluated under 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 na tional provisions applicable to those 
materials and articles. 
(6) The active and intelligent materials and arti cles may be composed of one or more 
layers or parts of different types of materi als, such as plastics,  paper and board or 
coatings and varnishes. Requirements fo r these materials may be either fully 
harmonised, or only partially harmonised, or  not yet harmonised at Community level. 
The present rules shou ld apply without prejudice to Community or national provisions 
that regulate these materials. 
(7) The individual substance or, if relevant , the combination of substances which 
constitute the components should be evaluate d to guarantee that they are safe and 
comply with the requirements set in Regul ation (EC) No 1935/2004. In some cases, it 
may be necessary to evaluate and authoris e the combination of substances, when the 
active or intelligent function implies interact ions between different substances leading 
to an enhancement of the function or the ge neration of new substances responsible for 
the active and intelligent function. 
(8) According to Regulation (EC) No 1935/2004, wh en 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 interest ed in placing on the market active and 
intelligent materials and articles or the co mponents, the applicant, should submit all 
the information necessary for the safety a ssessment 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 s hould be carried out by the European Food Safety 
Authority (the Authority), after the submi ssion of a valid application as set out in 
Articles 9 to 10 of Regulation (EC) No 1935/ 2004. In order to inform the applicant on 
the data to be provided for the safety assessment, the Author ity should publish a 
detailed guidance concerning the preparation and the submission of the application. In 
order to enable enforcement of possible restrictions it would be necessary that the 
applicant provides an appropria te analytical method for dete ction and quantification of 
the substance. The Authority should evaluate  if the analytical method is suitable for 
the purpose of enforcement of  the suggested restriction. EN 4   EN (11) The safety assessment of a spec ific substance or of a combin ation of substances should 
be followed by a risk management decision as to whether the substance should be included in the Community list of substances that can be used in active and intelligent 
components (Community list). That decision s hould be adopted in accordance with the 
regulatory procedure described in arti cle 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 iden tity, restrictions or specifications or 
conditions of use of that substance or of  a combination of substances and, where 
necessary, of the component or of the materi al and article in which they are added or 
incorporated into. The identity  of a substance should at l east include the name and if 
available and necessary CAS numbers, particle size, composition or other 
specifications. 
(13) Active materials and articles may deliber ately 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. In case the Community or national 
provisions foresee an authorisation of the substance, the substance and its use should 
fulfil the requirements of the authorisati on under the specific le gislation on food e.g. 
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 us er with information on the conditions of 
the food and should not release their const ituents 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, whic h is a barrier within food c ontact materials or articles 
preventing the migration of substances from  behind this 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 susc eptible 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 th e migration of a non-authorised substance 
through a functional barrie r. New technologies that engineer  substances in particle size 
that exhibit chemical and physical propertie s that significantly differ from those at 
larger scale e.g. nanoparticles should be assessed on a case by case  basis as regards 
their risk until more information is known about this new technology. Therefore they 
should not be covered by the functional barrier concept. 
(15) The specific Community measure covering the pa ssive part of the active or intelligent 
material may set down requirements for the in ertness of the material for example an 
overall migration limit applicable to plastic materials. If a rel easing active component 
is incorporated into a food contact material  covered by a specific Community measure, 
there may be the 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 subs tance should not be calculated in the value 
of overall migration. EN 5   EN (16) Article 4 (5) of Regulation (EC) No 1935/ 2004 provides that ac tive and intelligent 
materials and articles alread y brought into cont act with food shal l be adequately 
labelled to allow identifica tion by the consumer of non-edible parts. Consistency of 
such information seems indispensable to avoi d confusion at consumer level. Therefore 
active and intelligent materials and articl es should be labelled with a phrasing and 
accompanied, where technically possible, by the symbol reproduced in the Annex, 
whenever materials and articles or pa rts of them are perceived as edible. 
(17) Article 16 of Regulation (EC) No 1935/2004 prov ides that materials and articles shall 
be accompanied by a written declaration of co mpliance 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 manufacture, the responsible pe rsons should document the compliance with 
the relevant rules in a declaration of compliance which is made available to his customer. Furthermore, at each stage of  manufacture, supporting documentation, 
substantiating the declarati on of compliance, should be kept available for the 
enforcement authorities. 
(18) Article 17(1) of Regul ation (EC) No 178/2002
5 requires the food business operator to 
verify that foods are compliant with the rule s applicable to them. Article 15 (1) (e) of 
Regulation (EC) No 1935/2004 pr ovides that materials and articles, which are not yet 
in contact with food when placed on the ma rket, shall 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 material s and articles to comply with any other 
relevant Community provisions or, in their absence, national provi sions applicable to 
food, including the provisions on food labelling. To this en d subject to th e 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 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 shoul d be allowed for the applicant to make 
available the information necessary for the safety assessment of the substance or the 
combination of substances which constitute s the component. Therefore, an 18 months 
period, should be allowed, during which 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 the 18 months 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 guidance of the Authority during the initial application phase. 
                                                
 
5  OJ L 31 of 1.2.2002, p.1. as last amended by Regulation (EC) No 202/2008 (OJ L 60 of 5.3.2008, p.17.) EN 6   EN (21) A Community list of those substances for which authorisation is proposed should be 
drafted by the Commission after the comple tion of the safety assessment of all 
substances for which a valid petition was submitted in accordance with the guidance 
of the Authority, during the in itial 18 months period. In orde r to ensure fair and equal 
conditions for all applicants, this Community list should be drawn up in a single step. 
(22) The measures provided for in this Regulati on are in accordance with the opinion of the 
[…] Committee, 
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
GENERAL PROVISIONS 
Article 1 
Subject matter 
This Regulation establishes specific requirement s for the marketing of active and intelligent 
materials and articles intended to  come into contact with food. 
The specific requirements are without prejud ice to Community or  national provisions 
applicable to the materials and articles to wh ich active or intelligent components are added or 
into which they are incorporated. 
Article 2 
Scope 
This Regulation shall apply to active and intel ligent 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 material s and articles that are intended to extend the 
shelf-life or to maintain or improve the condi tion of packaged food. They are designed to 
deliberately incorporate component s that would release or absorb  substances into or from 
the packaged food or the envi ronment surrounding the food; 
(b) "intelligent materials and articles" mean s materials and articles which monitor the 
condition of packaged food or th e environment surrounding the food; 
(c) "component” means an individual substance or a combination of i ndividual substances 
which cause the active and/or intelligent func tion of a material or article, including the 
products of in situ reaction of those substances. It does not in clude the passive parts, such 
as the material they are adde d to or incorporated into. EN 7   EN (d) “functional barrier” means a barrier consis ting 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 w ould release substances into or onto the 
packaged food or the environment surrounding the food. 
(f) “released active substances” are those substa nces intended to be released from releasing 
active materials and articles into or onto the packaged food or the environment surrounding the food and fulf illing 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 se t out in Article 15(1)(e ) of Regulation (EC) 
No 1935/2004; 
(e) comply with the composition, labelli ng and declaration requi rements set out in 
Chapters II, III and IV  of this Regulation. 
CHAPTER II 
 COMPOSITION  
SECTION 1 
COMMUNITY LIST OF AUHTORISED SUBSTANCES  
Article 5 
Community list of substances that may be  used in active and in telligent components 
1. Active and intelligent materials and articles may be placed on the market only if the 
substances which constitute the component of an active and intelligent material and article 
are included in the Community list of eligib le substances (hereina fter referred to as 
"Community list"). 
2. By way of derogation from paragraph 1 the following substances are not subject to the 
authorisation procedure provided under Artic le 9 of Regulation (EC) No 1935/2004 and 
thus shall not be included in the Community list in order to be used in active and intelligent materials and articles:  EN 8   EN (a) released active substances provided that they comply with  th e conditions set out in 
Article 9 of this Regulation; 
(b) substances falling under the scope of Comm unity or national provi sions applicable to 
food, which are incorporated in active materi als and articles by techniques such as 
grafting and immobilisation, in order to ha ve a technological e ffect in the food 
provided that they comply with  the conditi ons set out in Article 9 of this Regulation 
(c) substances used in components which ar e not in direct cont act with food or the 
environment surrounding the food and are separated from the food by a functional 
barrier provided that they comply with th e conditions set out in  Article 10 of this 
Regulation and that they do not fall in either of the following categories: 
(i) substances classified as "genot oxic", "carcinogenic ", or "toxic to 
reproduction" in accordance with the cr iteria set out in sections 3.5, 3.6 and 
3.7 of Annex I to Regulation (EC) No 1272/20086. 
(ii) substances deliberatel y engineered to particle size which exhibit functional 
physical and chemical properties that si gnificantly differ from those at larger 
scale 
Article 6 
Conditions for inclusion of subs tances in the Community list 
In order to be included in th e Community list, substances whic h constitute the component of 
active and intelligent materials and articles, mu st satisfy, the requirements of Article 3 and, 
where they apply, Article 4 of Regulation (EC) No 1935/2004 under the intended condition of use of the active and intelligent material a nd article in which they are incorporated. 
Article 7 
The 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 establishmen t of the Community list  
1. The Community list shall be drawn up on th e basis of applications made pursuant to 
Article 9 of Regula tion (EC) No 1935/2004. 
2. The deadline for submitting applications shal l be 18 months following the publication of 
                                                
 
6  OJ L353 of 31.12.2008, p.1. EN 9   EN the guidelines of the Authority for the safety assessment of substances  used in active and 
intelligent materials and articles. The Authority  shall at the latest 6 months after the 
publication of this Regulation publish guidelines for the safety assessment of substances 
to be used in active and intelligent materials and articles. 
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 Article 10 and 11 of Regulation (EC) No 1935/2004. 
5. Where the Authority calls for supplementary information and the applicant fails to 
provide the additional data within the set ti me limit the substance will not be evaluated 
by the Authority for the inclusion in the list as the application cannot be considered a valid application. 
6. The Commission adopts the Community list after the Authority has delivered its opinion 
on all substances included in the register for which a valid application is submitted 
pursuant to paragraphs 2 and 5. 
7. For the addition of new substances the pro cedure referred to in Articles 9 to 11 of 
Regulation (EC) No 193 5/2004 is applicable. 
SECTION 2  
CONDITIONS OF USE FOR SUBSTANCES NOT TO BE INCLUDED IN THE 
COMMUNITY LIST  
Article 9 
Substances referred to unde r Article 5(2) (a) and (b) 
1. Substances, as referred to in  Article 5(2) (a) and (b) of th is Regulation, shall be used in 
full compliance with the releva nt Community and national provisions applicable to 
food, and shall comply with the provisions  of Regulation (EC) No 1935/2004 and its 
implementing measures when applicable. 
2. The amount of a released active substance shall not be included in the value of the 
measured overall migration, in cases wher e 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 4 (3) of Regulation (EC) No 1935/2004, the 
amount of a released active substance mentioned in paragraph 2 may exceed the specific restriction established for that s ubstance in a specific Community or national 
measure on the food contact mate rials in which the component  is incorpor ated as long 
as it complies with the Community provision s applicable to food, or, if no Community 
provisions exist, with the nationa l provisions applicable to food. 
Article 10 
Substances referred to u nder Article. 5(2) (c) EN 10   EN 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 accord ance with Article 11 of Regulation (EC) No 882/2004 of the 
European Parliament and of the Council7. 
2. The limit set in paragraph 1 shall always be expressed as concentration in foods. It shall 
apply to a group of substances, if they are structurally and toxico logically related, in 
particular isomers or substan ces with the same relevant f unctional 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, ac tive and intelligent 
materials and articles or parts of them sha ll be labelled with the words "DO NOT EAT" 
and, always where technically possible, th e symbol reproduced in Annex I shall be 
indicated, whenever materials and articles or  parts of them are perceived as edible. 
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 l east 3mm and comply with 
the requirements provided under Arti cle15 of Regulation (EC) No 1935/2004. 
3. Released active substance shall be consider ed as ingredients within the meaning of 
Article 6(4)(a) of Directive 2000/13/EC8 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 po int of sale to the final consumer, active and 
intelligent materials and articles, whether or not they are in cont act with food, or the 
components intended for the manufacturing of those materials an d articles or the 
substances intended for the manufacturing of the components, shall be accompanied by a 
written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. 
2. That declaration referred to in paragraph 1 shall be issued  by the business operator and 
shall contain the information laid down in Annex II. 
                                                 
7  OJ L 191 of 28.5.2004, p.1. as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363 of 
20.12.2006, p.1.) 
8  OJ L 109 of 6.5.2000, p.29. as last amended by Directive 2003/89/EC (OJ L 308 of 25.11.2003, p.15) EN 11   EN Article 13 
Supporting documentation 
Appropriate documentation to demonstrate that the active and intelligent materials and articles 
as well as the components intended for the ma nufacturing of those ma terials and articles 
comply with the requirements of this Regulat ion shall be made available by the business 
operator to the national competent authorities on request. That documentation shall contain 
information on the suitability and effectivenes s of the active and intelligent material and 
article, conditions and results of  testing or calculations or othe r analysis, and evidence on the 
safety or 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 that of its publication in the 
Official Journal of the European Union . 
Article 5 shall apply from the date of application of the Community list. Until that date, 
national provisions in force concerning active and intelligent materials and articles shall 
continue to apply. 
Chapter IV shall apply after 6 months of the entry into force of this Regulation. 
Article 4(2) of Regulation (EC)  No 1935/2004 remains applicable until the date of application 
of the Community list. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission EN 12   EN ANNEX 1  
SYMBOL  
 EN 13   EN ANNEX 2  
DECLARATION OF COMPLIANCE 
The written declaration referred to in this Re gulation shall co ntain 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 ma nufactures or imports the 
active and intelligen t materials and articles, or the components intended for the 
manufacturing of those materials and arti cles, or the substances intended for the 
manufacturing of the components; 
3. the identity of the active a nd intelligent materials and articles or the components 
intended for the manufacturing of those mate rials and articles, or the substances 
intended for the manufacturing of the components; 
4. the date of the declaration; 
5. the confirmation that the active and intelligent material and article meets relevant 
requirements laid down in this Regula tion, Regulation (EC) No 1935/2004, and in 
specific measures applicable; 
6. adequate information relative to the substa nces which constitute the components, for 
which restrictions are in place under the Commun ity or national provisions applicable to 
food and this Regulation; where appropriate, specific purity criteri a in accordance with 
the relevant Community legisl ation applicable to food and, the name and quantity of the 
substances released by the active compone nt, to allow the downstream business 
operators to ensure complianc e with those restrictions;  
7. adequate information on the suitability and effectiveness of the active and intelligent 
material and article; 
8. specifications on the use of the component, such as: 
(i) group or groups of materials and articles  in which the component can be added or 
incorporated into; 
(ii) conditions of use necessary to achieving the intended effect. 
9. specifications on the use of the material and article, such as: 
(i) type or types of food intende d to be put in contact with; 
(ii) time and temperature of treatment and storage in contact with the food; 
(iii) ratio of food contact surface area to volu me 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 the requiremen ts of Article 12 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 produc tion bring about changes in the migration or 
when new scientific data are available.