Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) Text with EEA relevance

Article 1

Objectives

The objectives of this Regulation are to:

(a) implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the ‘Convention’);

(b) promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm;

(c) contribute to the environmentally sound use of hazardous chemicals.

The objectives set out in the first subparagraph shall be achieved by facilitating the exchange of information concerning the characteristics of hazardous chemicals, by providing for a decision-making process within the Union on their import and export and by disseminating decisions to Parties and other countries as appropriate.

Article 2

Scope

This Regulation shall apply to:

(a) certain hazardous chemicals that are subject to the prior informed consent procedure under the Convention (the ‘PIC procedure’);

(b) certain hazardous chemicals that are banned or severely restricted within the Union or a Member State;

(c) chemicals when exported in so far as their classification, labelling and packaging are concerned.

This Regulation shall not apply to any of the following:

(a) narcotic drugs and psychotropic substances covered by Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (¹);

(b) radioactive materials and substances covered by Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (²);

(c) wastes covered by Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (³);

(d) chemical weapons covered by Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items (⁴);

(e) food and food additives covered by 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 (⁵);

(f) feedingstuffs covered by 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 (⁶), including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

(g) genetically modified organisms covered by Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (⁷);

(h) save to the extent covered by Article 3(5)(b) of this Regulation, proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (⁸) and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (⁹) respectively.

Notwithstanding the first subparagraph, exporters of the chemicals referred to therein shall obtain a special reference identification number using the Database referred to in Article 6(1)(a) and provide that reference identification number in their export declaration.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘chemical’ means a substance, whether by itself or in a mixture, or a mixture, whether manufactured or obtained from nature, but does not include living organisms, which belongs to either of the following categories: (a) pesticides, including severely hazardous pesticide formulations; (b) industrial chemicals;

(2) ‘substance’ means any chemical element and its compounds as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

(3) ‘mixture’ means a mixture or a solution as defined in point 8 of Article 2 of Regulation (EC) No 1272/2008;

(4) ‘article’ means a finished product containing or including a chemical, the use of which has been banned or severely restricted by Union legislation in that particular product where that product does not fall under point 2 or 3;

(5) ‘pesticides’ means chemicals in either of the following subcategories: (a) pesticides used as plant protection products covered by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (¹⁰); (b) other pesticides, such as: (i) biocidal products under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (¹¹); and (ii) disinfectants, insecticides and parasiticides covered by Directives 2001/82/EC and 2001/83/EC;

(6) ‘industrial chemicals’ means chemicals in either of the following subcategories: (a) chemicals for use by professionals; (b) chemicals for use by the public;

(7) ‘chemical subject to export notification’ means any chemical that is banned or severely restricted within the Union within one or more categories or subcategories, and any chemical listed in Part 1 of Annex I that is subject to the PIC procedure;

(8) ‘chemical qualifying for PIC notification’ means any chemical that is banned or severely restricted within the Union or a Member State within one or more categories. Chemicals banned or severely restricted in the Union within one or more categories are listed in Part 2 of Annex I;

(9) ‘chemical subject to the PIC procedure’ means any chemical listed in Annex III to the Convention and in Part 3 of Annex I to this Regulation;

(10) ‘banned chemical’ means either of the following: (a) a chemical all uses of which within one or more categories or subcategories have been prohibited by final regulatory action by the Union in order to protect human health or the environment; (b) a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the Union market or from further consideration in a notification, registration or approval process and where there is evidence that the chemical raises concern for human health or the environment;

(11) ‘severely restricted chemical’ means either of the following: (a) a chemical, virtually all use of which within one or more categories or subcategories has been prohibited by final regulatory action by the Union in order to protect human health or the environment, but for which certain specific uses remain allowed; (b) a chemical that has, for virtually all uses, been refused for approval or been withdrawn by industry either from the Union market or from further consideration in a notification, registration or approval process, and where there is evidence that the chemical raises concern for human health or the environment;

(12) ‘chemical banned or severely restricted by a Member State’ means any chemical that is banned or severely restricted by national final regulatory action of a Member State;

(13) ‘final regulatory action’ means a legally binding act the purpose of which is to ban or severely restrict a chemical;

(14) ‘severely hazardous pesticide formulation’ means a chemical formulated for use as a pesticide that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use;

(15) ‘customs territory of the Union’ means the territory as determined in Article 3 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (¹²);

(16) ‘export’ means the following: (a) the permanent or temporary export of a chemical meeting the conditions of Article 28(2) TFEU; (b) the re-export of a chemical not meeting the conditions of Article 28(2) TFEU which is placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union;

(17) ‘import’ means the physical introduction into the customs territory of the Union of a chemical that is placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union;

(18) ‘exporter’ means any of the following persons, whether natural or legal: (a) the person on whose behalf an export declaration is made, that is to say the person who, at the time the declaration is accepted, holds the contract with the consignee in a Party or other country and has the power to determine that the chemical be sent out of the customs territory of the Union; (b) where no export contract has been concluded or where the holder of the contract does not act on its own behalf, the person who has the power to determine that the chemical be sent out of the customs territory of the Union; (c) where the benefit of a right to dispose of the chemical belongs to a person established outside the Union pursuant to the contract on which the export is based, the contracting party established in the Union;

(19) ‘importer’ means any natural or legal person who at the time of import into the customs territory of the Union is the consignee for the chemical;

(20) ‘Party to the Convention’ or ‘Party’ means a State or a regional economic integration organisation that has consented to be bound by the Convention and for which the Convention is in force;

(21) ‘other country’ means any country that is not a Party;

(22) ‘Agency’ means the European Chemicals Agency established under Regulation (EC) No 1907/2006;

(23) ‘Secretariat’ means the Secretariat of the Convention, unless otherwise specified in this Regulation.

Article 4

Designated national authorities of the Member States

Each Member State shall designate the authority or authorities (the ‘designated national authority’ or the ‘designated national authorities’) to carry out the administrative functions required by this Regulation, unless it has already done so before the entry into force of this Regulation.

It shall inform the Commission of such designation by 17 November 2012, unless that information has been already provided before entry into force of this Regulation, and shall also inform the Commission of any change of designated national authority.

Article 5

Participation of the Union in the Convention

The Commission shall, in particular, be responsible for the following:

(a) the transmission of Union export notifications to Parties and other countries pursuant to Article 8;

(b) the submission to the Secretariat of notifications of relevant final regulatory actions concerning chemicals qualifying for PIC notification pursuant to Article 11;

(c) the transmission of information concerning other final regulatory actions involving chemicals not qualifying for PIC notification in accordance with Article 12;

(d) the receiving of information from the Secretariat more generally.

The Commission shall also provide the Secretariat with Union import responses for chemicals subject to the PIC procedure pursuant to Article 13.

In addition, the Commission shall coordinate the Union input on all technical issues relating to the following:

(a) the Convention;

(b) the preparation of the Conference of the Parties established by Article 18(1) of the Convention;

(c) the Chemical Review Committee established in accordance with Article 18(6) of the Convention (the ‘Chemical Review Committee’);

(d) other subsidiary bodies of the Conference of the Parties.

Article 6

Tasks of the Agency

The Agency shall, in addition to the tasks allocated to it under Articles 7, 8, 9, 10, 11, 13, 14, 15, 18, 19, 20, 21, 22 and 25, carry out the following tasks:

(a) maintain, further develop and regularly update a database on export and import of hazardous chemicals (the ‘Database’);

(b) make the Database publicly available on its website;

(c) where appropriate, provide, with the agreement of the Commission and after consultations with Member States, assistance and technical and scientific guidance and tools for the industry in order to ensure the effective application of this Regulation;

(d) provide, with the agreement of the Commission, the designated national authorities of the Member States with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation;

(e) at the request of Member State or Commission experts of the Chemical Review Committee, and within the available resources, provide input in drafting of decision guidance documents referred to in Article 7 of the Convention and other technical documents related to the implementation of the Convention;

(f) upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation;

(g) upon request, provide the Commission with technical and scientific input and assist it in exercising its role as the common designated authority of the Union.

Article 7

Chemicals subject to export notification, chemicals qualifying for PIC notification, and chemicals subject to the PIC procedure

The chemicals listed in Part 1 of Annex I shall be subject to the export notification procedure laid down in Article 8, with detailed information being given on the identity of the substance, on the use category and/or subcategory subject to restriction, the type of restriction and, where appropriate, additional information, in particular on exemptions to requirements for export notification.

The chemicals listed in Part 2 of Annex I shall, in addition to being subject to the export notification procedure laid down in Article 8, qualify for the PIC notification procedure set out in Article 11, with detailed information being given on the identity of the substance and on the use category.

The chemicals listed in Part 3 of Annex I shall be subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification.

Article 8

Export notifications forwarded to Parties and other countries

The designated national authority of the exporter’s Member State shall check compliance of the information with Annex II and if the notification is complete forward it to the Agency no later than 25 days before the expected date of export.

The Agency shall, on behalf of the Commission, transmit the notification to the designated national authority of the importing Party or the appropriate authority of the importing other country and take the measures necessary to ensure that they receive that notification no later than 15 days before the first intended export of the chemical and thereafter no later than 15 days before the first export in any subsequent calendar year.

The Agency shall register each export notification and assign it a reference identification number in the Database. The Agency shall also make available to the public and the designated national authorities of the Member States, as appropriate, an updated list of the chemicals concerned and the importing Parties and other countries for each calendar year by means of the Database.

Without prejudice to the obligations set out in Article 19(2), the obligations set out in paragraphs 2, 3 and 4 of this Article shall cease when all of the following conditions are fulfilled:

(a) the chemical has become a chemical subject to the PIC procedure;

(b) the importing country is a Party to the Convention and has provided the Secretariat with a response in accordance with Article 10(2) of the Convention indicating whether or not it consents to import of the chemical; and

(c) the Commission has been informed of that response by the Secretariat and has forwarded that information to the Member States and the Agency.

Notwithstanding the first subparagraph of this paragraph, the obligations set out in paragraphs 2, 3 and 4 of this Article shall not cease where an importing country is a Party to the Convention and explicitly requires continued export notification by exporting Parties, for example through its import decision or otherwise.

Without prejudice to the obligations set out in Article 19(2), the obligations set out in paragraphs 2, 3 and 4 of this Article shall also cease when both of the following conditions are fulfilled:

(a) the designated national authority of the importing Party or the appropriate authority of the importing other country has waived the requirement to be notified before the export of the chemical; and

(b) the Commission has received the information from the Secretariat or from the designated national authority of the importing Party or the appropriate authority of the importing other country and has forwarded it to the Member States and the Agency, which has made it available by means of the Database.

Article 9

Export notifications received from Parties and other countries

The Agency shall, on behalf of the Commission, acknowledge receipt of the first export notification received for each chemical from each Party or other country.

The designated national authority of the Member State receiving that import shall receive a copy of any notification received by the Agency, within 10 days of its receipt, together with all available information. Other Member States shall be entitled to receive copies on request.

Article 10

Information on export and import of chemicals

Each exporter of one or more of the following:

(a) substances listed in Annex I;

(b) mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances; or

(c) articles containing substances listed in Part 2 or 3 of Annex I in unreacted form or mixtures containing such substances in a concentration that triggers labelling obligations under Regulation (EC) No 1272/2008 irrespective of the presence of any other substances;

shall, during the first quarter of each year, inform the designated national authority of the exporter’s Member State regarding the quantity of the chemical, as a substance and as contained in mixtures or in articles, shipped to each Party or other country during the preceding year. That information shall be given together with a list of the names and addresses of each natural or legal person importing the chemical into a Party or other country to which shipment took place during the same period. That information shall list separately exports pursuant to Article 14(7).

Each importer within the Union shall provide the equivalent information for the quantities imported into the Union.

Article 11