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 approx ­
imation 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 Regu ­
lation (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 incor ­
porated into the packaging material, for example, incor ­
poration 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.EN 30.5.2009 Official Journal of the European Union L 135/3  
( 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.(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 appli ­
cation, in accordance with Articles 9 and 10 of Regu ­
lation (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 tech ­
nological 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 infor ­
mation 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 func ­
tional 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 particu ­
larly 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 estab ­
lished 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 isEN L 135/4 Official Journal of the European Union 30.5.2009indispensable 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 (  1 ) 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 accom ­
panied 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 intel ­
ligent 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 tran ­
sition 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 infor ­
mation 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 infor ­
mation 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 appli ­
cations 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.EN 30.5.2009 Official Journal of the European Union L 135/5  
( 1 ) OJ L 31, 1.2.2002, p. 1.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 combi ­
nation 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 tech ­
niques 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 (  1 );EN L 135/6 Official Journal of the European Union 30.5.2009  
( 1 ) OJ L 353, 31.12.2008, p. 1.(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 appli ­
cation 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.EN 30.5.2009 Official Journal of the European Union L 135/7Article 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 (  1 ). 
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 ingre ­
dients within the meaning of Article 6(4)(a) of Directive 
2000/13/EC of the European Parliament and of the 
Council (  2 ) 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 manu ­
facturing 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 demon ­
strating 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 appli ­
cation of the Community list. Until that date, and without 
prejudice to the requirements set out in Article 4(2) of Regu ­
lation (EC) No 1935/2004 and Articles 9 and 10 of this Regu ­
lation, 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 Regu ­
lation (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.EN L 135/8 Official Journal of the European Union 30.5.2009  
( 1 ) OJ L 165, 30.4.2004, p. 1.  
( 2 ) OJ L 109, 6.5.2000, p. 29.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 CommissionEN 30.5.2009 Official Journal of the European Union L 135/9ANNEX I  
SYMBOL
EN L 135/10 Official Journal of the European Union 30.5.2009ANNEX 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.EN 30.5.2009 Official Journal of the European Union L 135/11