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
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/regulation/2011/284@2011-03-22/en
Contents
- Preamble
- Article 1 Subject matter
- Article 2 Definitions
- Article 3 Import conditions
- Article 4 Prior notification of consignments
- Article 5 Notification of the first point of introduction
- Article 6 Controls at the first point of introduction
- Article 7 Onward transportation
- Article 8 Release for free circulation
- Article 9 Reporting to the Commission
- Article 10 Entry into force
- ANNEX
- 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
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, and in particular Article 48(1) thereof,
Whereas:
(1) Commission Directive 2002/72/EC 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 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 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 ex39241000;
(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
ANNEX
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
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)
Versions
Cited by
- Commission Recommendation (EU) 2019/794 of 15 May 2019 on a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food (notified under document C(2019) 3519) (Text with EEA relevance) Act · Grade B
Commission Regulation (EU) No 284/2011 lays 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, including mandatory physical controls of 10 % of consignments by Member States. The Regulation was introduced on the basis of elevated numbers of non-compliances due to the release of high levels of PAA from polyamide plastic food contact materials and formaldehyde from melamine plastic food contact materials.
- Commission Recommendation (EU) 2019/794 of 15 May 2019 on a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food (notified under document C(2019) 3519) (Text with EEA relevance) Act · Grade B
A recent analysis of data based on controls carried out at the point of import into the European Union and reported in accordance with Article 9 of Regulation (EU) No 284/2011 indicates a decrease in non-compliance of these products. Nevertheless, RASFF data shows that some of these products are still non-compliant based on results from analysis of samples taken from the market. Information also shows that the origin of such products is not restricted to China and Hong Kong. It is therefore appropriate to control levels of PAA and formaldehyde in addition to the controls carried out under Regu
- Commission Recommendation (EU) 2019/794 of 15 May 2019 on a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food (notified under document C(2019) 3519) (Text with EEA relevance) Act · Grade B
Sample descriptions and methodology The table below sets out the types of food contact materials, which should be sampled together with the substances for which migration from those food contact materials should be analysed, except in the case of fluorinated compounds for which the quantity in the material should be analysed. Sampling should include the point of import for food contact materials from third countries, although Member States should take into account controls already being undertaken in accordance with Regulation (EU) No 284/2011. Member States should also undertake market contro
- Council Decision (EU) 2017/1391 of 17 July 2017 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to that Agreement Decision · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation within the timeframes listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for approximation Chapter I — General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2016 Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the orga
- Council Decision (EU) 2016/2354 of 12 December 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(4) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — Veterinary Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC 2015 Commission Regulation (EC) No 1505/2006 of 11 October 2006 implementing Council Regulation (EC) No 21/2004 as regards the minimum
- Council Decision (EU) 2016/877 of 23 May 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Subcommittee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part Decision · Grade B
In accordance with Article 181(4) of this Agreement, the Republic of Moldova shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — General Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, with the exception of Articles 58, 59 and 62 2016 Commission Regulation (EC) No 1304/2003
- Council Decision 2019/1748 of 7 October 2019 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to Chapter 4 of that Agreement Act · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation with the deadlines for adoption as listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for adoption Chapter I – General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2018 Council Directive No 97/78/EC of 18 December 1997 laying down the principles governi
- Council Decision (EU) 2023/187 of 23 January 2023 on the position to be adopted on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(1) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes listed below. Union legislation Deadline for approximation Section 1 - Veterinary 1. Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97. 2015 2. Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 Ma
- 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) (Text with EEA relevance) Regulation · Grade B
The approval of border inspection posts in accordance with Article 6 of Directive 97/78/EC and Article 6 of Directive 91/496/EEC, the designation of points of entry in accordance with Article 5 of Regulation (EC) No 669/2009 and with Article 13c(4) of Directive 2000/29/EC and the designation of first points of introduction in accordance with Article 5 of Commission Regulation (EU) No 284/2011 shall be withdrawn.
- Position (EU) No 1/2017 of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council 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) Adopted by the Council on 19 December 2016 (Text with EEA relevance) 2017/C 55/01 Notice · Grade B
The approval of border inspection posts in accordance with Article 6 of Directive 97/78/EC and Article 6 of Directive 91/496/EEC, the designation of points of entry in accordance with Article 5 of Regulation (EC) No 669/2009 and with Article 13c(4) of Directive 2000/29/EC and the designation of first points of introduction in accordance with Article 5 of Commission Regulation (EU) No 284/2011 shall be withdrawn.