23.4.2010 EN Official Journal of the European Union L 102/1 COMMISSION REGULATION (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation No 19/65/EEC of the Council of 2 March 1965 on the application of Article 85(3) of the Treaty to certain categories of agreements and concerted practices (1), and in particular Article 1 thereof, Having published a draft of this Regulation, After consulting the Advisory Committee on Restrictive Practices and Dominant Positions, Whereas: (1) Regulation No 19/65/EEC empowers the Commission to apply Article 101(3) of the Treaty on the Functioning of the European Union (2) by regulation to certain categories of vertical agreements and corresponding concerted practices falling within Article 101(1) of the Treaty. (2) Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices (3) defines a category of vertical agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. In view of the overall positive experience with the application of that Regulation, which expires on 31 May 2010, and taking into account further experience acquired since its adoption, it is appropriate to adopt a new block exemption regulation. (3) The category of agreements which can be regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty includes vertical agreements for the purchase or sale of goods or services where those agreements are concluded between non-competing undertakings, between certain competitors or by certain associations of retailers of goods. It also includes vertical agreements containing ancillary provisions on the assignment or use of intellectual property rights. The term ‘vertical agreements’ should include the corresponding concerted practices. (4) For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those vertical agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the market structure on the supply and purchase side. (5) The benefit of the block exemption established by this Regulation should be limited to vertical agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty. (6) Certain types of vertical agreements can improve economic efficiency within a chain of production or distribution by facilitating better coordination between the participating undertakings. In particular, they can lead to a reduction in the transaction and distribution costs of the parties and to an optimisation of their sales and investment levels. (7) The likelihood that such efficiency-enhancing effects will outweigh any anti-competitive effects due to restrictions contained in vertical agreements depends on the degree of market power of the parties to the agreement and, therefore, on the extent to which those undertakings face competition from other suppliers of goods or services regarded by their customers as interchangeable or substitutable for one another, by reason of the products' characteristics, their prices and their intended use. (8) It can be presumed that, where the market share held by each of the undertakings party to the agreement on the relevant market does not exceed 30 %, vertical agreements which do not contain certain types of severe restrictions of competition generally lead to an improvement in production or distribution and allow consumers a fair share of the resulting benefits. (9) Above the market share threshold of 30 %, there can be no presumption that vertical agreements falling within the scope of Article 101(1) of the Treaty will usually give rise to objective advantages of such a character and size as to compensate for the disadvantages which they create for competition. At the same time, there is no presumption that those vertical agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty. (10) This Regulation should not exempt vertical agreements containing restrictions which are likely to restrict competition and harm consumers or which are not indispensable to the attainment of the efficiency-enhancing effects. In particular, vertical agreements containing certain types of severe restrictions of competition such as minimum and fixed resale-prices, as well as certain types of territorial protection, should be excluded from the benefit of the block exemption established by this Regulation irrespective of the market share of the undertakings concerned. (11) In order to ensure access to or to prevent collusion on the relevant market, certain conditions should be attached to the block exemption. To this end, the exemption of non-compete obligations should be limited to obligations which do not exceed a defined duration. For the same reasons, any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers should be excluded from the benefit of this Regulation. (12) The market-share limitation, the non-exemption of certain vertical agreements and the conditions provided for in this Regulation normally ensure that the agreements to which the block exemption applies do not enable the participating undertakings to eliminate competition in respect of a substantial part of the products in question. (13) The Commission may withdraw the benefit of this Regulation, pursuant to Article 29(1) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (4), where it finds in a particular case that an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty. (14) The competition authority of a Member State may withdraw the benefit of this Regulation pursuant to Article 29(2) of Regulation (EC) No 1/2003 in respect of the territory of that Member State, or a part thereof where, in a particular case, an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty in the territory of that Member State, or in a part thereof, and where such territory has all the characteristics of a distinct geographic market. (15) In determining whether the benefit of this Regulation should be withdrawn pursuant to Article 29 of Regulation (EC) No 1/2003, the anti-competitive effects that may derive from the existence of parallel networks of vertical agreements that have similar effects which significantly restrict access to a relevant market or competition therein are of particular importance. Such cumulative effects may for example arise in the case of selective distribution or non compete obligations. (16) In order to strengthen supervision of parallel networks of vertical agreements which have similar anti-competitive effects and which cover more than 50 % of a given market, the Commission may by regulation declare this Regulation inapplicable to vertical agreements containing specific restraints relating to the market concerned, thereby restoring the full application of Article 101 of the Treaty to such agreements, HAS ADOPTED THIS REGULATION: Article 1 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) ‘vertical agreement’ means an agreement or concerted practice entered into between two or more undertakings each of which operates, for the purposes of the agreement or the concerted practice, at a different level of the production or distribution chain, and relating to the conditions under which the parties may purchase, sell or resell certain goods or services; (b) ‘vertical restraint’ means a restriction of competition in a vertical agreement falling within the scope of Article 101(1) of the Treaty; (c) ‘competing undertaking’ means an actual or potential competitor; ‘actual competitor’ means an undertaking that is active on the same relevant market; ‘potential competitor’ means an undertaking that, in the absence of the vertical agreement, would, on realistic grounds and not just as a mere theoretical possibility, in case of a small but permanent increase in relative prices be likely to undertake, within a short period of time, the necessary additional investments or other necessary switching costs to enter the relevant market; (d) ‘non-compete obligation’ means any direct or indirect obligation causing the buyer not to manufacture, purchase, sell or resell goods or services which compete with the contract goods or services, or any direct or indirect obligation on the buyer to purchase from the supplier or from another undertaking designated by the supplier more than 80 % of the buyer's total purchases of the contract goods or services and their substitutes on the relevant market, calculated on the basis of the value or, where such is standard industry practice, the volume of its purchases in the preceding calendar year; (e) ‘selective distribution system’ means a distribution system where the supplier undertakes to sell the contract goods or services, either directly or indirectly, only to distributors selected on the basis of specified criteria and where these distributors undertake not to sell such goods or services to unauthorised distributors within the territory reserved by the supplier to operate that system; (f) ‘intellectual property rights’ includes industrial property rights, know how, copyright and neighbouring rights; (g) ‘know-how’ means a package of non-patented practical information, resulting from experience and testing by the supplier, which is secret, substantial and identified: in this context, ‘secret’ means that the know-how is not generally known or easily accessible; ‘substantial’ means that the know-how is significant and useful to the buyer for the use, sale or resale of the contract goods or services; ‘identified’ means that the know-how is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality; (h) ‘buyer’ includes an undertaking which, under an agreement falling within Article 101(1) of the Treaty, sells goods or services on behalf of another undertaking; (i) ‘customer of the buyer’ means an undertaking not party to the agreement which purchases the contract goods or services from a buyer which is party to the agreement. 2. For the purposes of this Regulation, the terms ‘undertaking’, ‘supplier’ and ‘buyer’ shall include their respective connected undertakings. ‘Connected undertakings’ means: (a) undertakings in which a party to the agreement, directly or indirectly: (i) has the power to exercise more than half the voting rights, or (ii) has the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking, or (iii) has the right to manage the undertaking's affairs; (b) undertakings which directly or indirectly have, over a party to the agreement, the rights or powers listed in point (a); (c) undertakings in which an undertaking referred to in point (b) has, directly or indirectly, the rights or powers listed in point (a); (d) undertakings in which a party to the agreement together with one or more of the undertakings referred to in points (a), (b) or (c), or in which two or more of the latter undertakings, jointly have the rights or powers listed in point (a); (e) undertakings in which the rights or the powers listed in point (a) are jointly held by: (i) parties to the agreement or their respective connected undertakings referred to in points (a) to (d), or (ii) one or more of the parties to the agreement or one or more of their connected undertakings referred to in points (a) to (d) and one or more third parties. Article 2 Exemption 1. Pursuant to Article 101(3) of the Treaty and subject to the provisions of this Regulation, it is hereby declared that Article 101(1) of the Treaty shall not apply to vertical agreements. This exemption shall apply to the extent that such agreements contain vertical restraints. 2. The exemption provided for in paragraph 1 shall apply to vertical agreements entered into between an association of undertakings and its members, or between such an association and its suppliers, only if all its members are retailers of goods and if no individual member of the association, together with its connected undertakings, has a total annual turnover exceeding EUR 50 million. Vertical agreements entered into by such associations shall be covered by this Regulation without prejudice to the application of Article 101 of the Treaty to horizontal agreements concluded between the members of the association or decisions adopted by the association. 3. The exemption provided for in paragraph 1 shall apply to vertical agreements containing provisions which relate to the assignment to the buyer or use by the buyer of intellectual property rights, provided that those provisions do not constitute the primary object of such agreements and are directly related to the use, sale or resale of goods or services by the buyer or its customers. The exemption applies on condition that, in relation to the contract goods or services, those provisions do not contain restrictions of competition having the same object as vertical restraints which are not exempted under this Regulation. 4. The exemption provided for in paragraph 1 shall not apply to vertical agreements entered into between competing undertakings. However, it shall apply where competing undertakings enter into a non-reciprocal vertical agreement and: (a) the supplier is a manufacturer and a distributor of goods, while the buyer is a distributor and not a competing undertaking at the manufacturing level; or (b) the supplier is a provider of services at several levels of trade, while the buyer provides its goods or services at the retail level and is not a competing undertaking at the level of trade where it purchases the contract services. 5. This Regulation shall not apply to vertical agreements the subject matter of which falls within the scope of any other block exemption regulation, unless otherwise provided for in such a regulation. Article 3 Market share threshold 1. The exemption provided for in Article 2 shall apply on condition that the market share held by the supplier does not exceed 30 % of the relevant market on which it sells the contract goods or services and the market share held by the buyer does not exceed 30 % of the relevant market on which it purchases the contract goods or services. 2. For the purposes of paragraph 1, where in a multi party agreement an undertaking buys the contract goods or services from one undertaking party to the agreement and sells the contract goods or services to another undertaking party to the agreement, the market share of the first undertaking must respect the market share threshold provided for in that paragraph both as a buyer and a supplier in order for the exemption provided for in Article 2 to apply. Article 4 Restrictions that remove the benefit of the block exemption — hardcore restrictions The exemption provided for in Article 2 shall not apply to vertical agreements which, directly or indirectly, in isolation or in combination with other factors under the control of the parties, have as their object: (a) the restriction of the buyer's ability to determine its sale price, without prejudice to the possibility of the supplier to impose a maximum sale price or recommend a sale price, provided that they do not amount to a fixed or minimum sale price as a result of pressure from, or incentives offered by, any of the parties; (b) the restriction of the territory into which, or of the customers to whom, a buyer party to the agreement, without prejudice to a restriction on its place of establishment, may sell the contract goods or services, except: (i) the restriction of active sales into the exclusive territory or to an exclusive customer group reserved to the supplier or allocated by the supplier to another buyer, where such a restriction does not limit sales by the customers of the buyer, (ii) the restriction of sales to end users by a buyer operating at the wholesale level of trade, (iii) the restriction of sales by the members of a selective distribution system to unauthorised distributors within the territory reserved by the supplier to operate that system, and (iv) the restriction of the buyer's ability to sell components, supplied for the purposes of incorporation, to customers who would use them to manufacture the same type of goods as those produced by the supplier; (c) the restriction of active or passive sales to end users by members of a selective distribution system operating at the retail level of trade, without prejudice to the possibility of prohibiting a member of the system from operating out of an unauthorised place of establishment; (d) the restriction of cross-supplies between distributors within a selective distribution system, including between distributors operating at different level of trade; (e) the restriction, agreed between a supplier of components and a buyer who incorporates those components, of the supplier’s ability to sell the components as spare parts to end-users or to repairers or other service providers not entrusted by the buyer with the repair or servicing of its goods. Article 5 Excluded restrictions 1. The exemption provided for in Article 2 shall not apply to the following obligations contained in vertical agreements: (a) any direct or indirect non-compete obligation, the duration of which is indefinite or exceeds five years; (b) any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services; (c) any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers. For the purposes of point (a) of the first subparagraph, a non-compete obligation which is tacitly renewable beyond a period of five years shall be deemed to have been concluded for an indefinite duration. 2. By way of derogation from paragraph 1(a), the time limitation of five years shall not apply where the contract goods or services are sold by the buyer from premises and land owned by the supplier or leased by the supplier from third parties not connected with the buyer, provided that the duration of the non-compete obligation does not exceed the period of occupancy of the premises and land by the buyer. 3. By way of derogation from paragraph 1(b), the exemption provided for in Article 2 shall apply to any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services where the following conditions are fulfilled: (a) the obligation relates to goods or services which compete with the contract goods or services; (b) the obligation is limited to the premises and land from which the buyer has operated during the contract period; (c) the obligation is indispensable to protect know-how transferred by the supplier to the buyer; (d) the duration of the obligation is limited to a period of one year after termination of the agreement. Paragraph 1(b) is without prejudice to the possibility of imposing a restriction which is unlimited in time on the use and disclosure of know-how which has not entered the public domain. Article 6 Non-application of this Regulation Pursuant to Article 1a of Regulation No 19/65/EEC, the Commission may by regulation declare that, where parallel networks of similar vertical restraints cover more than 50 % of a relevant market, this Regulation shall not apply to vertical agreements containing specific restraints relating to that market. Article 7 Application of the market share threshold For the purposes of applying the market share thresholds provided for in Article 3 the following rules shall apply: (a) the market share of the supplier shall be calculated on the basis of market sales value data and the market share of the buyer shall be calculated on the basis of market purchase value data. If market sales value or market purchase value data are not available, estimates based on other reliable market information, including market sales and purchase volumes, may be used to establish the market share of the undertaking concerned; (b) the market shares shall be calculated on the basis of data relating to the preceding calendar year; (c) the market share of the supplier shall include any goods or services supplied to vertically integrated distributors for the purposes of sale; (d) if a market share is initially not more than 30 % but subsequently rises above that level without exceeding 35 %, the exemption provided for in Article 2 shall continue to apply for a period of two consecutive calendar years following the year in which the 30 % market share threshold was first exceeded; (e) if a market share is initially not more than 30 % but subsequently rises above 35 %, the exemption provided for in Article 2 shall continue to apply for one calendar year following the year in which the level of 35 % was first exceeded; (f) the benefit of points (d) and (e) may not be combined so as to exceed a period of two calendar years; (g) the market share held by the undertakings referred to in point (e) of the second subparagraph of Article 1(2) shall be apportioned equally to each undertaking having the rights or the powers listed in point (a) of the second subparagraph of Article 1(2). Article 8 Application of the turnover threshold 1. For the purpose of calculating total annual turnover within the meaning of Article 2(2), the turnover achieved during the previous financial year by the relevant party to the vertical agreement and the turnover achieved by its connected undertakings in respect of all goods and services, excluding all taxes and other duties, shall be added together. For this purpose, no account shall be taken of dealings between the party to the vertical agreement and its connected undertakings or between its connected undertakings. 2. The exemption provided for in Article 2 shall remain applicable where, for any period of two consecutive financial years, the total annual turnover threshold is exceeded by no more than 10 %. Article 9 Transitional period The prohibition laid down in Article 101(1) of the Treaty shall not apply during the period from 1 June 2010 to 31 May 2011 in respect of agreements already in force on 31 May 2010 which do not satisfy the conditions for exemption provided for in this Regulation but which, on 31 May 2010, satisfied the conditions for exemption provided for in Regulation (EC) No 2790/1999. Article 10 Period of validity This Regulation shall enter into force on 1 June 2010. It shall expire on 31 May 2022. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 April 2010. For the Commission The President José Manuel BARROSO (1) OJ 36, 6.3.1965, p. 533. (2) With effect from 1 December 2009, Article 81 of the EC Treaty has become Article 101 of the Treaty on the Functioning of the European Union. The two Articles are, in substance, identical. For the purposes of this Regulation, references to Article 101 of the Treaty on the Functioning of the European Union should be understood as references to Article 81 of the EC Treaty where appropriate. (3) OJ L 336, 29.12.1999, p. 21. (4) OJ L 1, 4.1.2003, p. 1.

Summary: Exemption for vertical supply and distribution agreements Exemption for vertical supply and distribution agreements SUMMARY OF: Regulation (EU) No 330/2010 — application of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices Article 101 of the Treaty on the Functioning of the European Union (TFEU) WHAT IS THE AIM OF THE REGULATION AND OF ARTICLE 101 TFEU? Article 101(1) TFEU prohibits agreements that may affect trade between EU countries and which prevent, restrict or distort competition. However, agreements which create sufficient benefits to outweigh the anti-competitive effects are exempt from this prohibition under Article 101(3) TFEU. The regulation gives a block exemption from Article 101(1) TFEU to vertical agreements* which fulfil certain requirements. These agreements may, for instance, help a manufacturer to enter a new market, or avoid the situation whereby one distributor ‘free rides’ on the promotional efforts of another distributor, or allow a supplier to depreciate an investment made for a particular client. KEY POINTS Requirements for application of the regulation Certain requirements must be fulfilled before a particular vertical agreement is exempt from Article 101(1) TFEU: the agreement does not contain any of the ‘hardcore’ restrictions set out in the regulation; there must be a market share cap of 30% for both suppliers and buyers; the regulation contains conditions relating to 3 specific restrictions. ‘Hardcore’ restrictions There are 5 restrictions that lead to the exclusion of the whole agreement from the benefit of the regulation, even if the market shares of the supplier and buyer are below 30%. They are considered to be severe restrictions of competition because of the likely harm they cause to consumers. In most cases they will be prohibited and it is considered unlikely that vertical agreements containing them fulfil the conditions of Article 101(3) TFEU: 1.suppliers are not allowed to fix the (minimum) price at which distributors can resell their products (resale price maintenance); 2.market-partitioning by territory or by customer is prohibited. Distributors must remain free to decide where and to whom they sell. The regulation contains exceptions to this rule, which, for instance, enable companies to operate an exclusive distribution system or a selective distribution system; 3.selected distributors, while being prohibited to sell to unauthorised distributors, cannot be restricted in the end-users to whom they may sell; 4.selected distributors must remain free to sell or purchase the contract goods to or from other selected distributors within the network; 5.an agreement between a manufacturer of spare parts and a buyer which incorporates these parts into its own products may not prevent or restrict sales by the manufacturer of these spare parts to end-users, independent repairers or service providers. The 30% market share cap A vertical agreement is covered by this regulation if neither the supplier nor the buyer of the goods or services has a market share exceeding 30%. For the supplier, it is its market share on the relevant supply market, i.e. the market on which it sells the goods or services that is decisive for the application of the block exemption. For the buyer, it is its market share on the relevant purchase market, i.e. the market on which it purchases the goods or services, which is decisive for the application of the regulation. The excluded restrictions The regulation applies to all vertical restraints other than those mentioned above. However, it does impose specific conditions on 3 vertical restraints: obligations not to compete during the contract; obligations not to compete after termination of the contract; the exclusion of specific brands in a selective distribution system. When these conditions are not fulfilled, these vertical restraints are excluded from the exemption by the regulation. However, the regulation continues to apply to the remaining part of the vertical agreement if that part can operate independently from the non-exempted vertical restraints.The European Commission has also published guidelines on vertical restraints. These describe the approach taken towards vertical agreements not covered by the regulation. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 June 2010 and will expire on 31 May 2022. BACKGROUND For more information, see: Vertical agreements (European Commission) Antitrust: Commission adopts revised competition rules for vertical agreements: frequently asked questions (European Commission). Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted: Communication from the Commission — Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak KEY TERMS Vertical agreements: agreements for the sale and purchase of goods or services between companies operating at different levels of the production or distribution chain, for example, distribution agreements between manufacturers and wholesalers or retailers. MAIN DOCUMENTS Commission Regulation (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices (OJ L 102, 23.4.2010, pp. 1-7) Consolidated version of the Treaty on the Functioning of the European Union — Part Three — Union policies and internal actions — Title VII — Common rules on competition, taxation and approximation of laws — Chapter 1 — Rules on competition — Section 1 — Rules applying to undertakings — Article 101 (ex Article 81 TEC) (OJ C 202, 7.6.2016, pp. 88-89) RELATED DOCUMENTS Guidelines on Vertical Restraints (OJ C 130, 19.5.2010, pp. 1-46) last update 08.05.2020


6.4.2011 EN Official Journal of the European Union L 90/1 COUNCIL DECISION of 9 March 2011 on the conclusion of the Agreement between the European Community and the Government of Japan on cooperation in science and technology (2011/213/EU) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 186 in conjunction with point (v) of Article 218(6)(a) thereof, Having regard to the proposal from the European Commission, Having regard to the consent of the European Parliament, Whereas: (1) The Commission negotiated, on behalf of the European Community, an Agreement on cooperation in science and technology with the Government of Japan. (2) That Agreement was signed by the representatives of the Parties on 30 November 2009 in Brussels subject to its conclusion at a later date. (3) As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community. (4) The Agreement should be concluded on behalf of the Union, HAS ADOPTED THIS DECISION: Article 1 The Agreement between the European Community and the Government of Japan on cooperation in science and technology is hereby approved on behalf of the Union. The text of the Agreement is attached to this Decision. Article 2 The Commission shall adopt the position to be taken by the Union in the Joint Committee established by Article 6(1) of the Agreement with regard to amendments to the Agreement according to Article 13(5) of the Agreement. Article 3 The President of the Council shall, on behalf of the Union, give the notification provided for in Article 13(1) of the Agreement and make the following notification to the Government of Japan: ‘As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community and from that date exercises all rights and assumes all obligations of the European Community. Therefore, references to “the European Community” in the text of the Agreement are, where appropriate, to be read as “the European Union”.’ Article 4 This Decision shall enter into force on the day of its adoption. Done at Brussels, 9 March 2011. For the Council The President CSÉFALVAY Z. AGREEMENT between the European Community and the Government of Japan on cooperation in science and technology THE EUROPEAN COMMUNITY hereinafter referred to as ‘the Community’ and THE GOVERNMENT OF JAPAN DESIRING to further promote the close and friendly relations existing between Japan and the Community, and being aware of the rapid development of scientific knowledge and of its positive contribution in promoting bilateral and international cooperation; WISHING to broaden the scope of cooperation in science and technology in a number of areas of common interest through the creation of a productive partnership for peaceful purposes and for their mutual benefit; BELIEVING that such cooperation and the application of the results of such cooperation contribute to the economic and social development of Japan and the Community; DESIRING to establish a formal framework for the conduct of the overall cooperative activities which will strengthen cooperation in science and technology between the Parties; HAVE AGREED AS FOLLOWS: Article 1 1. The Parties shall encourage, develop and facilitate cooperative activities under this Agreement in the areas of science and technology for peaceful purposes. 2. The cooperative activities under this Agreement shall be conducted on the basis of the following principles: (a) mutual and equitable contributions and benefits; (b) reciprocal access to research and development programmes and projects and facilities for visiting researchers; (c) timely exchange of information which may affect the cooperative activities under this Agreement; (d) promotion of a knowledge-based society for the benefit of the economic and social development of Japan and the Community. Article 2 1. The cooperative activities under this Agreement consist of direct cooperative activities and indirect cooperative activities. 2. For the purpose of this Agreement: (a) the term ‘the Parties’ means the Government of Japan and the Community; (b) the term ‘direct cooperative activities’ means cooperative activities between the Parties or their agencies; (c) the term ‘indirect cooperative activities’ means cooperative activities between persons of Japan and the Community carried out under research and development programmes and projects; (d) the term ‘research and development programmes and projects’ means the Framework Programme for research and technological development operated by the Community or research and development programmes and projects with the competitive funding system operated by the Government of Japan, its agencies or official institutions; (e) the term ‘persons’ means: (i) with respect to Japan, any nationals of Japan or any legal persons established under the national laws of Japan; and (ii) with respect to the Community, any nationals of the Member States of the Community or any legal persons established under the national laws of the Member States of the Community or the Community law; (f) the term ‘agencies’ means: (i) with respect to Japan, the governmental agencies of Japan; and (ii) with respect to the Community, the European Commission; (g) the term ‘official institutions’ means official institutions whose budgets and operating plans are approved by the competent Ministers of the Government of Japan, and whose research and development programmes and projects with the competitive funding system are included, with their consent, into those programmes and projects for indirect cooperative activities; (h) the term ‘intellectual property rights’ shall have the meaning given to ‘intellectual property’ in Article 2 of the Convention Establishing the World Intellectual Property Organization, signed at Stockholm on July 14, 1967. Article 3 1. Forms of the direct cooperative activities may include the following: (a) meetings of various forms, such as those of experts, to discuss and exchange information on scientific and technological aspects of general or specific subjects and to identify research and development programmes and projects that may be usefully undertaken on a cooperative basis; (b) exchange of information on activities, policies, practices, and laws and regulations concerning research and development; (c) visits and exchanges of scientists, technical personnel, or other experts on general or specific subjects; (d) implementation of any other forms of cooperative activities as may be identified, proposed and decided at the Joint Committee on Scientific and Technological Cooperation referred to in Article 6 of this Agreement. 2. For the purpose of developing indirect cooperative activities, any person of a Party can participate in research and development programmes and projects, operated by the other Party, its agencies or official institutions, in accordance with the laws and regulations of the other Party, and subject to Annexes I and II to this Agreement. Article 4 The details and procedures of each cooperative activity under this Agreement may be decided between the Parties, their agencies or official institutions engaged in that cooperative activity. Article 5 With regard to the direct cooperative activities under this Agreement, each Party or its agencies may allow, as appropriate, with the consent of the other Party or its agencies, the participation of researchers and organisations from all sectors of the research establishment including the private sector. Article 6 1. For the purpose of effective implementation of this Agreement, the Parties shall establish a Joint Committee on Scientific and Technological Cooperation (hereinafter referred to as ‘the Joint Committee’). The Joint Committee shall be co-chaired by officials of the Ministry of Foreign Affairs of Japan and of the European Commission. 2. The functions of the Joint Committee shall be: (a) exchanging information and views on scientific and technological policy issues; (b) identifying, proposing and deciding the cooperative activities under this Agreement; (c) reviewing and discussing the accomplishments of the cooperative activities under this Agreement; (d) providing advice and encouragement to the Parties with regard to the implementation of this Agreement; (e) reviewing regularly the reciprocal access to research and development programmes and projects and arrangements for visiting researchers and examining concrete measures to improve that access and to ensure the effectiveness of the principle on reciprocity mentioned in Article 1 of this Agreement. 3. Decisions of the Joint Committee shall be reached by mutual consent. 4. The Joint Committee shall meet at mutually convenient times, preferably at least once every 2 years. 5. The Government of Japan and the Community shall host alternately the Joint Committee meeting, unless otherwise agreed. 6. For the Joint Committee meeting, the expenses for travel and accommodation of the participants will be borne by the Party to whom they relate. Any other costs associated with the Joint Committee meeting will be borne by the host Party. 7. The Joint Committee will adopt its own internal rules of procedure. 8. The Joint Committee may make decisions through diplomatic channels when it is not in session. Article 7 Implementation of this Agreement shall be subject to the availability of appropriated funds and to the applicable laws and regulations of each Party. Article 8 1. Scientific and technological information of a non-proprietary nature resulting from direct cooperative activities may be made available to the public by either Party through customary channels and in accordance with the normal procedures of the participating agencies. 2. Intellectual property rights and undisclosed information resulting from, introduced in the course of, or obtained through the cooperative activities under this Agreement shall be treated in accordance with the provisions of Annex II to this Agreement. Article 9 Each Party shall make every effort, within the framework of its laws and regulations, to accord to the persons, carrying out the cooperative activities under this Agreement, all possible facilities with a view to facilitating the free movement and stay of researchers participating in those cooperative activities and to facilitating the entry into and exit from its territory of materials, data or equipment intended for use in those cooperative activities. Article 10 The provisions of this Agreement shall not prejudice rights and obligations with respect to existing and future agreements for cooperation between the Parties or between the Government of Japan and the Government of any Member State of the Community. Article 11 All questions or disputes related to the interpretation or implementation of this Agreement shall be settled by mutual consultation between the Parties. Article 12 Annexes I and II to this Agreement form an integral part of this Agreement. Article 13 1. This Agreement shall enter into force on the date on which the Parties exchange diplomatic notes informing each other that their respective internal procedures necessary for the entry into force of this Agreement have been completed. 2. This Agreement shall remain in force for 5 years and shall continue in force thereafter unless terminated by either Party at the end of the initial 5-year period or at any time thereafter by giving to the other Party at least 6 months’ written advance notice of its intention to terminate this Agreement. 3. The termination of this Agreement shall not affect carrying out of the cooperative activities undertaken under this Agreement and not fully executed at the time of the termination of this Agreement, or any specific rights and obligations that have accrued in compliance with Annex II to this Agreement. 4. Each Party may evaluate the impact of this Agreement and activities under this Agreement every 5 years, and the Party which does so shall inform the other Party of the results of the evaluation. Each Party will make every effort to facilitate the evaluation conducted by the other Party. 5. This Agreement may be amended by mutual consent of the Parties through diplomatic notes exchanged between them. Amendments shall enter into force under the same conditions as mentioned in paragraph 1 above, unless otherwise agreed. This Agreement and Annexes I and II of this Agreement are drawn up in two originals in each of the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Japanese languages with each of these texts being equally authentic. In case of divergence of interpretation, the English and Japanese texts shall prevail over the other language texts. IN WITNESS WHEREOF, the undersigned, being duly authorised thereto by the European Community and the Government of Japan respectively, have signed this Agreement. Done at Brussels, this thirtieth day of November, 2009. For the European Community For the Government of Japan ANNEX I TERMS AND CONDITIONS FOR THE PARTICIPATION OF PERSONS IN RESEARCH AND DEVELOPMENT PROGRAMMES AND PROJECTS I. Where within the framework of this Agreement a Party, its agencies or official institutions conclude a contract with a person of the other Party for research and development programmes and projects, the other Party shall, when requested, endeavour to provide any reasonable and feasible assistance as may be necessary or helpful for the former Party, its agencies or official institutions to facilitate the smooth implementation of such contract. II. Persons of Japan may participate in the Framework Programme for research and technological development operated by the Community. Such participation of persons of Japan shall be in accordance with the rules for participation, dissemination and implementation of the Framework Programme. III. Persons of the Community may participate in research and development programmes and projects with the competitive funding system operated by the Government of Japan, its agencies or official institutions in scientific and technological fields similar to those of the Framework Programme for research and technological development. Such participation of persons of the Community shall be in accordance with the laws and regulations of Japan and the relevant rules for participation, dissemination and implementation of the specific programme or project. ANNEX II INTELLECTUAL PROPERTY RIGHTS AND UNDISCLOSED INFORMATION I. Intellectual property rights of the Parties in direct cooperative activities 1. The following rules shall apply to intellectual property rights resulting from direct cooperative activities, except copyright and related rights referred to in paragraph 3 below: (a) the intellectual property rights shall be owned by the Party or its agencies which generate the intellectual property. Where the intellectual property has been generated jointly, the Parties or their agencies shall consult to agree upon the ownership or allocation of the intellectual property rights taking into account the respective share of the work of the Parties or their agencies; (b) the Party or its agencies owning the intellectual property rights shall grant a licence to use such rights to the other Party or its agencies for carrying out any direct cooperative activity if this is needed to enable the other Party or its agencies to carry out their own work for the specific project under this Agreement. In case of patents and utility models, this licence shall be granted on a royalty-free basis. The granting of a licence to use any intellectual property rights under this subparagraph shall be subject to the applicable laws and regulations of each Party, and the conditions to be agreed upon between the Parties or their agencies prior to the start of the project. 2. The Party or its agencies owning the intellectual property rights introduced in the course of direct cooperative activities shall grant a licence to use such rights to the other Party or its agencies for carrying out any direct cooperative activity if this is needed to enable the other Party or its agencies to carry out their own work for the specific project under this Agreement. The granting of a licence to use any intellectual property rights under this paragraph shall be subject to the applicable laws and regulations of each Party, and the conditions to be agreed upon between the Parties or their agencies prior to the start of the project. 3. The following rules shall apply to copyright and related rights of the Parties or their agencies: (a) where a Party or its agencies publish scientific and technical data, information and results by means of journals, articles, reports, books, video tapes and digital storage devices, resulting from direct cooperative activities, the Party will make its best efforts to obtain for the other Party a non-exclusive, irrevocable and royalty-free licence in all countries where copyright protection is available to translate, reproduce, adapt, transmit and publicly distribute such works; (b) all publicly distributed copies of a copyrighted work under the provisions of subparagraph (a) above shall indicate the name(s) of the author(s) of the work unless an author explicitly declines to be named. They shall also bear a clearly visible acknowledgement of the cooperative support of the Parties. II. Undisclosed information in direct cooperative activities The following rules shall apply to undisclosed information of the Parties or their agencies: 1. When communicating to the other Party or its agencies information necessary to carry out direct cooperative activities, each Party shall identify that information it wishes to remain undisclosed. 2. The Party or its agencies receiving undisclosed information may, under its own responsibility, communicate such undisclosed information to its agencies or persons within or employed by themselves if this is needed to enable those agencies or persons to carry out their own work for the specific project under this Agreement. 3. With the prior written consent of a Party or its agencies providing undisclosed information, the other Party or its agencies may disseminate such undisclosed information more widely than otherwise permitted in paragraph 2 above. The Parties or their agencies shall cooperate with each other in developing procedures for requesting and obtaining prior written consent for such wider dissemination, and each Party will grant such consent to the extent permitted by its laws and regulations. 4. Information obtained through seminars, other meetings, assignment of staff and use of facilities arranged under this Agreement, shall remain confidential where the recipient of such undisclosed or other confidential or privileged information was made aware of the confidential character of the information communicated at the time such communication was made according to paragraph 1 above, and be treated as indicated in paragraphs 2 and 3 above. 5. If a Party becomes aware that it will be, or may be reasonably expected to become, unable to meet the restrictions and conditions of dissemination in paragraphs 2, 3 and 4 above, it shall immediately inform the other Party. The Parties shall thereafter consult to define an appropriate course of action. III. Intellectual property rights of persons in indirect cooperative activities Each Party shall ensure that the intellectual property rights of persons of the other Party participating in research and development programmes and projects operated by the former Party, its agencies or official institutions, and the related rights and obligations resulting from such participation, shall be consistent with the relevant international conventions which are binding on the Government of Japan and the Community or all its Member States, including the Agreement on Trade-Related Aspects of Intellectual Property Rights in Annex 1C to the Marrakech Agreement Establishing the World Trade Organization, as well as the Paris Act of July 24, 1971 of the Berne Convention for the Protection of Literary and Artistic Works and the Stockholm Act of July 14, 1967 of the Paris Convention for the Protection of Industrial Property.

Summary: Scientific and technological cooperation between the EU and Japan Scientific and technological cooperation between the EU and Japan SUMMARY OF: Agreement between the European Community and the Government of Japan on cooperation in science and technology Decision 2011/213/EU — conclusion of the Agreement between the European Community and the Government of Japan on cooperation in science and technology WHAT IS THE AIM OF THE AGREEMENT AND THE DECISION? The agreement establishes a formal framework for cooperation, aiming at encouraging, developing and facilitating activities in the areas of science and technology for peaceful purposes. By its decision, the Council approved the conclusion of the agreement on behalf of the European Community (now the EU). KEY POINTS Activities conducted under the agreement are based on the following principles: mutual and equitable contributions and benefits; reciprocal access to research and development programmes, projects and facilities for visiting researchers; timely exchange of information; promotion of a knowledge-based society for the benefit of the economic and social development of the EU and Japan. Cooperation The agreement covers two forms of cooperative activities: direct cooperative activities between the parties including meetings for example, of experts to discuss and exchange information on scientific and technological aspects of general or specific subjects andto identify research and development projects and programmes that may be usefully undertaken on a cooperative basisexchange of information on activities, policies, practices, and laws and regulations concerning research and developmentvisits and exchanges of scientists, technical personnel and other experts on general or specific subjectsother forms of cooperative activities decided on by the Joint Committee on Scientific and Technological Cooperation; indirect cooperative activities: any person* from one of the parties can take part in the research and development programmes and projects of the other party (or its agencies or official institutions) in accordance with that other party’s laws and regulations, and subject to Annexes I and II of the agreement. DATE OF ENTRY INTO FORCE The agreement entered into force on 29 March 2011 for an initial period of five years. After that, it remains in force unless it is terminated by either party. BACKGROUND The EU–Japan Economic Partnership Agreement (which entered into force on 1 February 2019) and the EU–Japan Strategic Partnership Agreement (a large part of it provisionally applicable as of 1 February 2019) represent a significant strengthening of the EU’s partnership with Japan. For more information, see: Japan and the EU (European External Action Service). For more information about Research and Innovation (R&I) cooperation with Japan, see: International R&I cooperation — Japan (European Commission) Roadmap for EU–Japan S&T Cooperation (European Commission) KEY TERMS Person:with respect to Japan, any nationals of Japan or any legal persons established under the national laws of Japanwith respect to the EU, any nationals of the EU countries or any legal persons established under EU law or national laws of the EU countries MAIN DOCUMENTS Agreement between the European Community and the Government of Japan on cooperation in science and technology (OJ L 90, 6.4.2011, pp. 2-7) Council Decision 2011/213/EU of 9 March 2011 on the conclusion of the Agreement between the European Community and the Government of Japan on cooperation in science and technology (OJ L 90, 6.4.2011, p. 1) last update 12.09.2019


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

Summary: Import of plastic kitchenware from China 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