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)Text with EEA relevance

• Celex Number: 02012R0649-20231101
• Coming into Force: 01 November 2023
• Date: 01 November 2023
• Published date: 01 November 2023

02012R0649 — EN — 01.11.2023 — 007.001

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►B 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) (OJ L 201 27.7.2012, p. 60)

Amended by:

		Official Journal
		No	page	date
M1	COMMISSION DELEGATED REGULATION (EU) No 1078/2014 of 7 August 2014	L 297	1	15.10.2014
M2	COMMISSION DELEGATED REGULATION (EU) 2015/2229 of 29 September 2015	L 317	13	3.12.2015
M3	COMMISSION DELEGATED REGULATION (EU) 2018/172 of 28 November 2017	L 32	6	6.2.2018
M4	COMMISSION DELEGATED REGULATION (EU) 2019/330 of 11 December 2018	L 59	1	27.2.2019
M5	COMMISSION DELEGATED REGULATION (EU) 2019/1701 of 23 July 2019	L 260	1	11.10.2019
M6	COMMISSION DELEGATED REGULATION (EU) 2020/1068 of 15 May 2020	L 234	1	21.7.2020
►M7	COMMISSION DELEGATED REGULATION (EU) 2022/643 of 10 February 2022	L 118	14	20.4.2022
►M8	COMMISSION DELEGATED REGULATION (EU) 2023/1656 of 16 June 2023	L 210	1	25.8.2023

Corrected by:

C1 Corrigendum, OJ L 363, 18.12.2014, p. 185 (1078/2014)

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▼B

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

1.

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.

2.

In addition to the objectives set out in paragraph 1, this Regulation shall ensure that the provisions of Regulation (EC) No 1272/2008 relating to classification, labelling and packaging apply to all chemicals when they are exported from the Member States to other Parties or other countries, unless those provisions would conflict with any specific requirements of those Parties or other countries.

Article 2

Scope

1.

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.

2.

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.

3.

This Regulation shall not apply to chemicals exported for the purpose of research or analysis in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10 kg from each exporter to each importing country per calendar year.

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...