CELEX ID: 32011R0284

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Document:
23.3.2011
EN
Official Journal of the European Union
L 77/25
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 hexamethylenetetramine).
(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.
(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 introduction 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 Regulation (EC) No 882/2004, should be defined in this Regulation. 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.
Article 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 formaldehyde 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 accompanied by a laboratory report providing:
(a)
as regards polyamide kitchenware, analytical results demonstrating 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 demonstrating 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 originating 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.
Article 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 BARROSO
(
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
.
ANNEX
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
Text of image
Name and full address (including telephone or e-mail address) of the natural or legal person issuing this declaration
Name and full address (including telephone or e-mail address) of the business operator(s) which manufacture(s) the plastic kitchenware of the consignment
Name and full address (including telephone or e-mail address) of the business operator which is responsible for the first introduction in the Union of the consignment
Identification code of the consignment:
Type and number of articles in the consignment:
This consignment contains plastic kitchenware made of:
polyamide
Analytical tests have been carried out demonstrating that the articles do not release PAA in a detectable quantity
The detection limit of the method used is …
The results of these tests as well as the description of the method of analysis used are attached to this document
melamine
Analytical tests have been carried out demonstrating that the articles do not release formaldehyde in a quantity exceeding the SML of 15 mg/kg
The results of these tests as well as the description of the method of analysis used are attached to this document
List of documents annexed confirming that the consignment meets the requirements concerning the release of primary aromatic amines or formaldehyde laid down in Directive 2002/72/EC:
The undersigned, as importer in the Union of the consignment, confirms that such consignment meets the requirements concerning the release of primary aromatic amines or formaldehyde laid down in Directive 2002/72/EC
Place and date
Name of signatory
Signature
Full address (including telephone and e-mail address)
Declaration of the competent authority on the consignment:
Acceptable for release into free circulation:
Conforms
Does not conform
Place and date
Name of signatory
Signature
Full address (including telephone and e-mail address)

Summary:
Import of plastic kitchenware from China
SUMMARY OF:
Regulation (EU) 284/2011 — conditions and procedures for the import of plastic kitchenware from China and Hong Kong
WHAT IS THE AIM OF THE REGULATION?
It sets out specific conditions and procedures for the import into the EU of the macromolecule polyamide and melamine plastic kitchenware originating or in consignment from China or Hong Kong.
KEY POINTS
Import conditions
The competent authority at the first point of introduction into the EU must carry out 
documentary checks on all consignments
 and 
identity and physical checks on 10% of consignments
. Only then may the goods be released onto the market.
To demonstrate compliance and to facilitate the checks, an importer must submit a declaration for each consignment to the competent national authority. This confirms that the consignment meets requirements concerning the release of the organic compounds 
primary aromatic amines
 and 
formaldehyde
. The declaration must include a laboratory report showing that: 
polyamide kitchenware does not release primary aromatic amines into foods or food simulants in a detectable quantity (the detection limit must be 0.01 mg/kg);
melamine kitchenware does not release formaldehyde into foods or food simulants in a quantity exceeding 15 mg/kg.
The authority must complete the physical checks as soon as technically feasible; from then on transportation is allowed but only when certain conditions are met.
The authority must indicate in the 
declaration
 whether the goods are acceptable or not for free circulation within the EU.
If the laboratory analysis reveals that a consignment does not comply with the import conditions, the 
European Commission
 must be immediately informed through the 
Rapid Alert System for Food and Feed
.
Regulation (EU) 
No 10/2011
 also applies to this kitchenware.
Notification
Importers must notify the authority at the first point of entry into the EU at least 
2 working days in advance
 of the estimated date and time of the physical arrival of their consignments.
If an EU country designates specific first points of entry, an up-to-date list must be published online and the internet address must be sent to the Commission.
A link to 
national lists of first points of entry
 is displayed on the Commission website for information purposes.
Reporting
Competent authorities must record: 
the country of origin of the consignment,
the number of articles in each consignment,
the number of consignments checked,
the results of the checks performed.
A report with this information must be sent to the Commission on a quarterly basis.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 
1 July 2011
.
BACKGROUND
For more information, see:
Food contact materials — Legislation
 (
European Commission
).
MAIN DOCUMENT
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 (OJ L 77, 
23.3.2011
, 
pp. 25-29
)
RELATED DOCUMENTS
Regulation (EU) 2017/625
 of the European Parliament and of the Council of 
15 March 2017
 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) 
No 999/2001
, (EC) 
No 396/2005
, (EC) 
No 1069/2009
, (EC) 
No 1107/2009
, (EU) 
No 1151/2012
, (EU) 
No 652/2014
, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) 
No 1/2005
 and (EC) 
No 1099/2009
 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) 
No 854/2004
 and (EC) 
No 882/2004
 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (official controls regulation) (OJ L 95, 
7.4.2017
, 
pp. 1-142
)
See 
consolidated version
Commission Regulation (EU) 
No 10/2011
 of 
14 January 2011
 on plastic materials and articles intended to come into contact with food (OJ L 12, 
15.1.2011
, 
pp. 1-89
)
Successive amendments to Regulation (EC) 
No 10/2011
 have been incorporated into the original text. This 
consolidated version
 is of documentary value only.
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
See 
consolidated version
.
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 (OJ L 165, 
30.4.2004
, 
pp. 1–141
). Text republished in 
corrigendum
 (OJ L 191, 
28.5.2004
, 
pp. 1–52
)
See 
consolidated version
.
EU guidelines for the import of polyamide and melamine kitchenware from China and Hong Kong
Technical guidelines concerning polyamide and melamine kitchenware including sampling and analytical methods 
last update 
11.11.2017

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