COMMISSION REGULATION (EU) No 284/2011  
of 22 March 2011  
laying down specific conditions and detailed procedures for the import of polyamide and melamine 
plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong 
Special Administrative Region, China  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Regulation (EC) No 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on official 
controls performed to ensure the verification of compliance 
with feed and food law, animal health and animal welfare 
rules (  1 ), and in particular Article 48(1) thereof,  
Whereas:  
(1) Commission Directive 2002/72/EC (  2 ) lays down specific 
provisions relating to plastic materials and articles 
intended to come into contact with foodstuffs, 
including compositional requirements, and restrictions 
and specifications for substances that may be used 
therein.  
(2) Several notifications and alerts have been received by the 
Rapid Alert System for Food and Feed pursuant to 
Article 50 of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council (  3 ) concerning 
food contact materials imported into the Union from 
the People’s Republic of China (hereinafter ‘China’) and 
Hong Kong Special Administrative Region of the People’s 
Republic of China (hereinafter ‘Hong Kong’), releasing 
into food or food simulant amounts of chemicals that 
are not in compliance with the Union legislation.  
(3) These notifications and alerts primarily concern 
polyamide and melamine plastic kitchenware that does 
not comply with the requirements concerning the release 
of primary aromatic amines and formaldehyde into food 
as laid down in Part A of Annex V and Section A of 
Annex II to Directive 2002/72/EC respectively.  
(4) Primary aromatic amines (hereinafter ‘PAA’) are a family 
of compounds, some of which are carcinogenic, while 
others of these compounds are suspected carcinogens. 
PAA may arise in materials intended for food contact 
as a result of the presence of impurities or breakdown 
products.  (5) Polyamide kitchenware originating in or consigned from 
China and Hong Kong has been reported to release high 
level of PAA into food.  
(6) Directive 2002/72/EC authorises the use of formaldehyde 
in the manufacture of plastics, provided that these 
plastics do not release into food more than 15 mg/kg 
of formaldehyde (specific migration limit (SML) 
expressed as total formaldehyde and hexamethylenetet ­
ramine).  
(7) Melamine kitchenware originating in or consigned from 
China and Hong Kong has been reported to release into 
food levels of formaldehyde that are higher than those 
authorised.  
(8) In the past few years, in order to increase knowledge of 
the requirements set out in Union legislation concerning 
food contact materials imported into the Union, the 
Commission has taken several initiatives, including 
training sessions for Chinese control authorities and the 
industry concerned.  
(9) Despite those initiatives, the missions of the Food and 
Veterinary Office to China and Hong Kong in 2009 
identified serious deficiencies in the official control 
system regarding plastic food contact materials intended 
for importation into the Union and large quantities of 
controlled polyamide and melamine plastic kitchenware 
originating in or consigned from China and Hong Kong 
still do not fulfil the requirements of Union legislation.  
(10) Regulation (EC) No 1935/2004 of the European 
Parliament and of the Council (  4 ) lays down specific 
provisions relating to the materials and articles 
intended to come into contact directly or indirectly 
with food, including certain general and specific 
requirements that these materials and articles should 
fulfil. Pursuant to Article 24 thereof, Member States 
shall carry out official controls in order to enforce 
compliance with that Regulation in accordance with the 
relevant provisions of Union law relating to official food 
and feed controls. Those provisions are laid down in 
Regulation (EC) No 882/2004.  
(11) More specifically, Article 48(1) of Regulation (EC) No 
882/2004 provides that in so far as Union legislation 
does not lay down the conditions and detailed 
procedures to be respected when importing goods from 
third countries, they may, if necessary, be laid down by 
the Commission.EN 23.3.2011 Official Journal of the European Union L 77/25  
( 1 ) OJ L 165, 30.4.2004, p. 1.  
( 2 ) OJ L 220, 15.8.2002, p. 18.  
( 3 ) OJ L 31, 1.2.2002, p. 1.  (  4 ) OJ L 338, 13.11.2004, p. 4.(12) Article 48(2) of Regulation (EC) No 882/2004 provides 
for the possibility to impose specific import conditions 
on particular products coming from certain third 
countries, taking into account the risks associated with 
these products.  
(13) In order to minimise the health risks that may arise from 
polyamide and melamine plastic kitchenware originating 
in or consigned from China or Hong Kong, each 
consignment of such products should be accompanied 
by appropriate documentation, including analytical 
results showing that it meets the requirements 
concerning the release of PAA and formaldehyde 
respectively, as laid down in Directive 2002/72/EC.  
(14) In order to ensure a more efficient organisation of the 
controls of polyamide and melamine plastic kitchenware 
originating in or consigned from China or Hong Kong, 
the importers or their representatives should give prior 
notification of the arrival and of the nature of the 
consignments. Likewise, Member States should have the 
possibility to designate specific first points of intro ­
duction through which consignments of these articles 
may enter the Union. This information should be 
publicly available.  
(15) In order to ensure a degree of uniformity at the Union 
level with regard to the controls of polyamide and 
melamine plastic kitchenware originating in or 
consigned from China or Hong Kong, the procedure 
for the official controls, as defined in Article 2 of Regu ­
lation (EC) No 882/2004, should be defined in this Regu ­
lation. These controls should include documentary, 
identity and physical checks.  
(16) In the event of non-compliance being identified during 
the physical checks, Member States should immediately 
inform the Commission through the Rapid Alert System 
for Food and Feed.  
(17) Member States should have the possibility, in specific 
cases, to authorise the onward transportation of 
consignments of polyamide and melamine plastic 
kitchenware originating in or consigned from China or 
Hong Kong from the first point of introduction, provided 
arrangements are made with the competent authority at 
the point of destination to ensure the traceability of the 
consignments pending the results of the physical checks, 
in order to allow the competent authority to deal with 
the process of importing such consignments effectively 
and efficiently.  
(18) The release into free circulation of polyamide and 
melamine plastic kitchenware originating in or 
consigned from China or Hong Kong should take place 
only once all the checks have been completed and the 
results are known. For that purpose the result of the 
controls should be made available to the customs 
authorities before the goods can be released for free 
circulation.  (19) A procedure for recording the information obtained from 
these controls should be established. This information 
should be submitted regularly to the Commission.  
(20) The provisions of this Regulation should be periodically 
reviewed, taking into account the information received 
from the Member States.  
(21) 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:  
Article 1  
Subject matter  
This Regulation lays down specific conditions and detailed 
procedures for the import of polyamide and of melamine 
plastic kitchenware originating in or consigned from the 
People’s Republic of China (hereinafter ‘China’) and Hong 
Kong Special Administrative Region of the People’s Republic 
of China (hereinafter ‘Hong Kong’).  
Article 2  
Definitions  
For the purpose of this Regulation the following definitions 
shall apply:  
(a) ‘plastic kitchenware’ means plastic materials as described in 
paragraphs 1 and 2 of Article 1 of Directive 2002/72/EC 
and falling within CN code ex 3924 10 00;  
(b) ‘consignment’ means a quantity of polyamide or melamine 
plastic kitchenware, covered by the same document(s), 
conveyed by the same means of transport and coming 
from the same third country;  
(c) ‘competent authorities’ means the competent authorities of 
the Member States designated in accordance with Article 4 
of Regulation (EC) No 882/2004;  
(d) ‘first point of introduction’ means the point of entry of a 
consignment into the Union;  
(e) ‘documentary check’ means the checking of the documents 
referred to in Article 3 of this Regulation;  
(f) ‘identity check’ means a visual inspection to ensure that the 
documents accompanying the consignment tally with the 
contents of the consignment;  
(g) ‘physical check’ means the sampling for analysis and 
laboratory testing and any other check necessary to verify 
compliance with the requirements concerning the release of 
PAA and formaldehyde laid down in Directive 2002/72/EC.EN L 77/26 Official Journal of the European Union 23.3.2011Article 3  
Import conditions  
1. Polyamide and melamine plastic kitchenware originating 
in or consigned from China and Hong Kong shall be imported 
into the Member States only if the importer submits to the 
competent authority for each consignment a declaration, duly 
completed, confirming that it meets the requirements 
concerning the release of primary aromatic amines and formal ­
dehyde laid down in Part A of Annex V and in Section A of 
Annex II to Directive 2002/72/EC respectively.  
2. A model of the declaration referred to in paragraph 1 is 
set out in the Annex to this Regulation. The declaration shall be 
drawn up in the official language, or in one of the official 
languages, of the Member State in which the consignment is 
imported.  
3. The declaration referred to in paragraph 1 shall be accom ­
panied by a laboratory report providing:  
(a) as regards polyamide kitchenware, analytical results demon ­
strating that they do not release into foods or food 
simulants primary aromatic amines in a detectable 
quantity. The detection limit applies to the sum of 
primary aromatic amines. For the purpose of the analysis 
the detection limit for primary aromatic amines is set at 
0,01 mg/kg food or food simulants;  
(b) as regards melamine kitchenware, analytical results demon ­
strating that they do not release into foods or food 
simulants formaldehyde in a quantity exceeding 15 mg/kg 
food.  
4. The competent authority shall indicate in the declaration 
set out in the Annex to this Regulation, whether the goods are 
acceptable or not for release into free circulation, depending on 
whether they fulfil the terms and conditions provided for in 
Directive 2002/72/EC as set out in paragraph 1.  
Article 4  
Prior notification of consignments  
Importers or their representatives shall notify the competent 
authority at the first point of introduction at least two 
working days in advance of the estimated date and time of 
physical arrival of consignments originating in or consigned 
from China and Hong Kong.  
Article 5  
Notification of the first point of introduction  
Where the Member States decide to designate specific first 
points of introduction for consignments originating in or 
consigned from China and Hong Kong, they shall publish on 
the Internet an up-to-date list of these points and communicate 
the Internet address to the Commission.  The Commission shall display on its website; for information 
purposes, the links to the national lists of specific first points of 
introduction.  
Article 6  
Controls at the first point of introduction  
1. The competent authority at the first point of introduction 
shall carry out:  
(a) documentary checks on all consignments within two 
working days from the time of their arrival;  
(b) identity and physical checks, including laboratory analysis of 
10 % of consignments, and in such a way that it is not 
possible for the importers or their representatives to 
predict whether any particular consignment will be 
subjected to such checks; the results of physical checks 
must be available as soon as technically possible.  
2. If the laboratory analysis referred to in point (b) of 
paragraph 1 identifies non-compliance, the competent 
authorities shall immediately inform the Commission of the 
results through the Rapid Alert System for Food and Feed 
established by Article 50 of Regulation (EC) No 178/2002.  
Article 7  
Onward transportation  
The competent authority at the first point of introduction may 
authorise the onward transportation of the consignments ori- 
ginating in or consigned from China and Hong Kong, pending 
the results of the checks referred to in point (b) of Article 6(1).  
If the competent authority grants the authorisation referred to 
in the first paragraph, it shall notify the competent authority at 
the point of destination and shall supply a copy of the 
declaration set out in the Annex, duly completed as provided 
in Article 3 and the results of the checks referred to in point (b) 
of Article 6(1), as soon as the latter are available.  
The Member States shall ensure that appropriate arrangements 
are put in place to ensure that the consignments remain under 
the continuous control of the competent authorities and cannot 
be tampered with in any way pending the results of the checks 
mentioned in point (b) of Article 6(1).  
Article 8  
Release for free circulation  
The release for free circulation of polyamide and melamine 
plastic kitchenware originating in or consigned from China 
and Hong Kong is subject to the presentation to the customs 
authorities of the declaration set out in the Annex duly 
completed as provided for in Article 3.EN 23.3.2011 Official Journal of the European Union L 77/27Article 9  
Reporting to the Commission  
1. When checks referred to in Article 6(1) are performed, the 
competent authorities shall keep records of the following 
information:  
(a) details of each consignment checked, including:  
(i) the size in terms of number of articles;  
(ii) the country of origin;  
(b) the number of consignments subject to sampling and 
analysis;  
(c) the results of the controls referred to in Article 6.  2. Member States shall submit to the Commission a report 
including the information referred to in paragraph 1, quarterly 
by the end of the month following each quarter.  
Article 10  
Entry into force  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
This Regulation shall apply from 1 July 2011.  
This Regulation shall be binding in its entirety and directly applicable in all Member States in 
accordance with the Treaties.  
Done at Brussels, 22 March 2011.  
For the Commission  
The President  
José Manuel BARROSOEN L 77/28 Official Journal of the European Union 23.3.2011ANNEX  
Declaration to be provided for every consignment of polyamide and melamine plastic kitchenware originating in 
or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China
EN 23.3.2011 Official Journal of the European Union L 77/29