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Regulation (EU) No 649/2012 of the European Parliament and of the CouncilShow full title

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)

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Changes over time for: Regulation (EU) No 649/2012 of the European Parliament and of the Council (without Annexes)

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Article 1U.K.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 [F1Great Britain] on their import and export and by disseminating decisions [F2to Parties, other countries and Northern Ireland] 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 [F3Great Britain][F4to other Parties, other countries or Northern Ireland], unless those provisions would conflict with any specific requirements [F5of those Parties, other countries or Northern Ireland].

Textual Amendments

Article 2U.K.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 [F6Great Britain];

(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 [F7the Ionising Radiations Regulations 2017];

(c)wastes covered by [F8the Waste (England and Wales) Regulations 2011 and the Waste (Scotland) Regulations 2011];

(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(2);

(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(3);

(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(4), including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

(g)genetically modified organisms covered by [F9the Genetically Modified Organisms (Deliberate Release) Regulations 2002 , the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 and the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002];

(h)save to the extent covered by Article 3(5)(b) of this Regulation, proprietary medicinal products and veterinary medicinal products covered by [F10the Human Medicines Regulations 2012] and [F11the Veterinary Medicines Regulations 2013] 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 [F12, or to Northern Ireland,] per calendar year.

Notwithstanding the first subparagraph, exporters of the chemicals referred to therein shall obtain a special reference identification number [F13from the exporter’s Designated National Authority] and provide that reference identification number in their export declaration.

Textual Amendments

Article 3U.K.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 [F14retained EU law] 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(5);

(b)

other pesticides, such as:

(i)

biocidal products under [F15Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products]; and

(ii)

disinfectants, insecticides and parasiticides covered by [F16the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012];

(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 [F17by retained EU law] within one or more categories or subcategories, and any chemical listed in Part 1 of [F18the GB PIC list] that is subject to the PIC procedure;

(8)

‘chemical qualifying for PIC notification’ means any chemical that is banned or severely restricted [F19by retained EU law] within one or more categories. Chemicals banned or severely restricted in [F20Great Britain] within one or more categories are listed in Part 2 of [F21the GB PIC list];

(9)

‘chemical subject to the PIC procedure’ means any chemical listed in [F22both] Annex III to the Convention and in Part 3 of [F23the GB PIC list];

(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 [F24retained EU law] 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 [F25Great Britain] 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 [F26retained EU law] 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 [F27Great Britain] 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)

F28...

(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)

F29...

(16)

[F30export” means:

(a)

the export of a chemical made in accordance with sections 33(4), 35 or 36 of the Taxation (Cross-border Trade) Act 2018;

(b)

the removal of a chemical from Great Britain to Northern Ireland; or

(c)

the export of a chemical where the chemicals are, immediately prior to export, in a temporary storage facility or subject to the control of any HMRC officer as described in paragraph 1(2) of Schedule 1 to the Taxation (Cross-border Trade) Act 2018,

but does not include chemicals which are under a transit procedure by which chargeable goods may be moved between places in Great Britain];

(17)

‘import’ means the [F31importation into Great Britain and release to a customs procedure, other than a transit procedure by which chargeable goods may be moved between places in Great Britain, of any chemical];

(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 [F32Party, other country or Northern Ireland] and has the power to determine that the chemical be sent out of [F33Great Britain];

(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 [F34Great Britain];

(c)

where the benefit of a right to dispose of the chemical belongs to a person established outside [F35Great Britain] pursuant to the contract on which the export is based, the contracting party established in [F35Great Britain];

(19)

‘importer’ means any natural or legal person who at the time of import into [F36Great Britain] 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)

F37...

(23)

‘Secretariat’ means the Secretariat of the Convention F38... ;

(24)

[F39‘Designated National Authority’ means the authority or authorities designated by the Secretary of State under the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 to carry out the administrative functions required by this Regulation;

(25)

‘exporter's Designated National Authority’ means the Designated National Authority of the country in which the exporter is established;

(26)

‘GB PIC list’ means the list established and maintained in accordance with Articles 7 and 23.]

Textual Amendments

F40Article 4U.K.Designated national authorities of the Member States

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 5U.K.Participation of the [F41United Kingdom] in the Convention

1.Participation in the Convention shall be [F42the] responsibility of the [F43Secretary of State], in particular as regards technical assistance, the exchange of information and matters relating to dispute settlement, participation in subsidiary bodies and voting.

[F442.The Designated National Authority must:

(a)transmit Great Britain export notifications to other Parties, countries and Northern Ireland pursuant to Article 8; and

(b)receive information from the Secretariat more generally.

2A.The Secretary of State must provide to the Secretariat:

(a)notifications of each relevant final regulatory action concerning chemicals qualifying for PIC notification pursuant to Article 11;

(b)information concerning other final regulatory actions involving chemicals not qualifying for PIC notification pursuant to Article 12; and

(c)Great Britain import responses for chemicals subject to the PIC procedure pursuant to Article 13.

2B.The Secretary of State must also coordinate the United Kingdom 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;

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

F453.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F46Article 6U.K.Tasks of the Designated National Authority

The Designated National Authority must, in addition to the tasks allocated to it under Articles 5, 7, 8, 9, 10, 11, 13, 14, 16, 18, 19 and 20, carry out the following tasks:

(a)where appropriate, provide assistance and guidance for industry in order to ensure the effective application of this Regulation;

(b)at the request of the Secretary of State, 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;

(c)upon request, provide the Secretary of State with technical and scientific input and assist the Secretary of State in order to ensure the effective implementation of this Regulation.]

Article 7U.K.Chemicals subject to export notification, chemicals qualifying for PIC notification, F47... chemicals subject to the PIC procedure [F48, chemicals subject to Regulation (EC) No 850/2004, and chemicals already subject to an export ban]

[F491.The Secretary of State must include the following chemicals in the GB PIC list:

(a)the chemicals subject to the export notification procedure under Article 8;

(b)the chemicals qualifying for the PIC notification procedure under Article 11;

(c)the chemicals subject to the PIC procedure as listed in Annex III to the Convention;

(d)the chemicals subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants; and

(e)the chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants that are already subject to an export ban.]

[F502.The Secretary of State must assign chemicals listed in the GB PIC list to one or more of the following groups:

(a)Part 1 of the GB PIC list, which lists chemicals that are 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;

(b)Part 2 of the GB PIC list, which lists chemicals that, 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;

(c)Part 3 of the GB PIC list, which lists chemicals that are subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification;

(d)Part 4 of the GB PIC list, which lists chemicals that are subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants;

(e)Part 5 of the GB PIC list, which lists chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants and are already subject to an export ban.]

3.[F51The Designated National Authority must make the GB PIC list] publicly available [F52via its website].

Textual Amendments

Article 8U.K.Export notifications forwarded to Parties and other countries

1.In the case of substances listed in Part 1 of [F53the GB PIC list] 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, paragraphs 2 to 8 of this Article shall apply regardless of the intended use of the chemical in the [F54importing Party, other country or Northern Ireland].

2.When an exporter is due to export a chemical referred to in paragraph 1 from [F55Great Britain][F56to a Party, other country or Northern Ireland] for the first time on or after the date on which it becomes subject to this Regulation, the exporter shall notify the [F57exporter's Designated National Authority], no later than 35 days before the expected date of export. Thereafter the exporter shall notify [F58the Designated National Authority] of the first export of the chemical each calendar year no later than 35 days before the export takes place. The notifications shall comply with the information requirements laid down in Annex II F59....

The [F60exporter's Designated National Authority] shall check compliance of the information with Annex II F61....

[F62The Designated National Authority must], transmit the notification to the designated national authority of the importing Party [F63or Northern Ireland] 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 [F64Designated National Authority][F65must maintain a list of export notifications and assign each export notification] a reference identification number F66.... The [F64Designated National Authority] shall also make available to the public F67... an updated list of the chemicals concerned and the [F68importing Parties, other countries and Northern Ireland] for each calendar year [F69via its website].

3.If the [F70Designated National Authority] does not receive from the [F71importing Party, other country or Northern Ireland] an acknowledgement of receipt of the first export notification made after the chemical is included in Part 1 of [F72the GB PIC list] within 30 days of the dispatch of such notification, it shallF73... submit a second notification. The [F74Designated National Authority] shallF75... make reasonable efforts to ensure that the designated national authority of the importing Party [F76or Northern Ireland] or the appropriate authority of the importing other country receives the second notification.

4.A new export notification shall be made in accordance with paragraph 2 for exports which take place subsequent to the entry into force of amendments to [F77retained EU law] concerning the marketing, use or labelling of the substances in question or whenever the composition of the mixture in question changes so that the labelling of such mixture is altered. The new notification shall comply with the information requirements laid down in Annex II and shall indicate that it is a revision of a previous notification.

5.Where the export of a chemical relates to an emergency situation in which any delay may endanger public health or the environment in [F78the importing Party, other country or Northern Ireland], an exemption from the obligations set out in paragraphs 2, 3 and 4 in whole or in part may be granted at the reasoned request of the exporter or [F78the importing Party, other country or Northern Ireland] and at the discretion of the [F79exporter’s Designated National Authority].

6.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 [F80, or in the case of Northern Ireland where such a response has been provided to the Secretariat indicating whether or not it consents to the import of the chemical]; and

(c)the [F81Designated National Authority] has been informed of that response by the Secretariat F82....

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 [F83, or in the case of Northern Ireland, where export notification by exporting Parties is explicitly required through the import decision relating to Northern Ireland 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 [F84or Northern Ireland] 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 [F85Designated National Authority] has received the information from the Secretariat or from the designated national authority of the importing Party [F86or Northern Ireland] or the appropriate authority of the importing other country [F87and has made it publicly available via its website].

7.[F88The Designated National Authority] and the exporters shall, on request, provide [F89importing Parties, other countries and Northern Ireland] with available additional information concerning the exported chemicals.

F908.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 9U.K.Export notifications received from Parties and other countries

1.F91...

[F92The Designated National Authority must] acknowledge receipt of the first export notification received [F93concerning the export to Great Britain of a chemical the manufacture, use, handling, consumption, transport or sale of which is subject to prohibition or severe restriction under the legislation of a Party, other country or Northern Ireland,] for each chemical from [F94each Party, other country or Northern Ireland].

F95...

F962.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 10U.K.Information on export and import of chemicals

1.Each exporter of one or more of the following:

(a)substances listed in [F97Part 1, 2 or 3 of the GB PIC list];

(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 [F98the GB PIC list] 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 [F99exporter’s Designated National Authority] regarding the quantity of the chemical, as a substance and as contained in mixtures or in articles, shipped to [F100each Party, other country or Northern Ireland] 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 [F101a Party, other country or Northern Ireland] to which shipment took place during the same period. That information shall list separately exports pursuant to Article 14(7).

Each importer within [F102Great Britain] shall provide the equivalent information for the quantities imported into [F102Great Britain].

2.At the request of the [F103Designated National Authority] the exporter or importer shall provide any additional information relating to chemicals that is necessary to implement this Regulation.

3.F104... The [F105Designated National Authority] shall make the non-confidential information publicly available [F106via its website].

Textual Amendments

Article 11U.K.Notification of banned or severely restricted chemicals under the Convention

1.The [F107Secretary of State] shall notify the Secretariat in writing of the chemicals listed in Part 2 of [F108the GB PIC list] which qualify for PIC notification.

2.Whenever further chemicals are added to Part 2 of [F109the GB PIC list] pursuant to the second subparagraph of Article 23(2), the [F110Secretary of State] shall notify those chemicals to the Secretariat. That PIC notification shall be submitted as soon as possible after adoption of the relevant final regulatory action F111... banning or severely restricting the chemical, and no later than 90 days after the date on which the final regulatory action is to be applied.

3.The PIC notification shall provide all relevant information required in Annex IV.

4.In determining priorities for notifications, the [F112Secretary of State] shall take into account whether the chemical is already listed in Part 3 of [F113the GB PIC list], the extent to which the information requirements laid down in Annex IV can be met, and the severity of the risks presented by the chemical, in particular for developing countries.

Where a chemical qualifies for PIC notification, but the information is insufficient to meet the requirements of Annex IV, identified exporters or importers shall, upon request by the [F114Designated National Authority], provide all relevant information available to them, including that from other national or international chemical control programmes, within 60 days of the request.

5.The [F115Secretary of State] shall notify the Secretariat in writing when a final regulatory action notified under paragraphs 1 or 2 is amended as soon as possible after adoption of the new final regulatory action, and no later than 60 days after the date on which the new final regulatory action is to be applied.

The [F115Secretary of State] shall provide all relevant information that was not available at the time the initial notification was made under paragraphs 1 or 2 respectively.

6.At the request of any Party or the Secretariat, the [F116Secretary of State] shall provide additional information concerning the chemical or the final regulatory action, as far as practicable.

F117...

7.F118...

[F119On the basis of the information that the Secretary of State receives from the Secretariat regarding chemicals notified as banned or severely restricted by other Parties, where] appropriate, the [F120Secretary of State] shall evaluate, in close cooperation with the [F121Designated National Authority, the Scottish Ministers and the Welsh Ministers], the need to [F122take] measures F123... in order to prevent any unacceptable risks to human health or the environment F124....

F1258.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 12U.K.Information to be transmitted to the Secretariat concerning banned or severely restricted chemicals not qualifying for PIC notification

In the case of chemicals listed only in Part 1 of [F126the GB PIC list, the Secretary of State] shall provide the Secretariat with information concerning the relevant final regulatory actions, so that the information can be disseminated to other Parties to the Convention as appropriate.

Article 13U.K.Obligations in relation to import of chemicals

1.F127...

[F128Where the Secretary of State receives a decision guidance document from the Secretariat, the Secretary of State must, taking into account the information in the decision guidance document], adopt an import decision in the form of a final or interim import response F129... concerning the future import of the chemical concerned. F130... The [F131Secretary of State] shall communicate the decision to the Secretariat as soon as possible, and no later than nine months after the date of dispatch of the decision guidance document by the Secretariat.

Where a chemical becomes subject to additional or amended restrictions F132..., the [F133Secretary of State] shallF134... adopt a revised import decision. F135... The [F133Secretary of State] shall communicate the revised import decision to the Secretariat.

F1362.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.An import decision under paragraph 1 shall relate to the category or categories specified for the chemical in the decision guidance document.

4.When communicating the import decision to the Secretariat, the [F137Secretary of State] shall provide a description of the legislative or administrative measure upon which it is based.

5.[F138The Designated National Authority] shall make the import decisions under paragraph 1 [F139publicly available via its website].

6.Where appropriate, the [F140Secretary of State] shall evaluate, in close cooperation with the [F141Designated National Authority, the Scottish Ministers and the Welsh Ministers], the need to [F142take] measures F143... in order to prevent any unacceptable risks to human health or the environment F144..., taking into account the information given in the decision guidance document.

[F1457.The functions of the Secretary of State under paragraph 1 to adopt an import decision and to adopt a revised import decision are subject to the consent requirement in Article 23B.]

Textual Amendments

Article 14U.K.Obligations in relation to export of chemicals other than export notification

1.[F146The Designated National Authority must make available via its website the information which it receives], whether in the form of circulars or otherwise, from the Secretariat regarding chemicals subject to the PIC procedure and the decisions of importing Parties regarding import conditions applicable to those chemicals. F147... The [F148Designated National Authority] shall assign each import decision a reference identification number and keep all information regarding such decisions publicly available [F149via its website].

F1502.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1513.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.Exporters shall comply with decisions in each import response no later than six months after the Secretariat first informs the [F152Designated National Authority] of such decisions under paragraph 1.

5.[F153The Designated National Authority] shall advise and assist importing Parties, upon request and as appropriate, in obtaining further information needed to prepare a response to the Secretariat concerning the import of a given chemical.

6.Substances listed in Part 2 or 3 of [F154the GB PIC list] 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, regardless of their intended use in the importing Party or other country, not be exported unless either of the following conditions is fulfilled:

(a)explicit consent to import has been sought and received by the exporter through the [F155exporter’s Designated National Authority], and the designated national authority of the importing Party [F156or Northern Ireland] or an appropriate authority in an importing other country;

(b)in the case of chemicals listed in Part 3 of [F157the GB PIC list], the latest circular issued by the Secretariat pursuant to paragraph 1 indicates that the importing Party has given consent to import [F158, or in the case of Northern Ireland the European Union has given consent to import].

In the case of chemicals listed in Part 2 of [F159the GB PIC list] that are to be exported to OECD countries, the [F160exporter’s Designated National Authority] may, at the request of the exporter, F161... decide that no explicit consent is required if the chemical, at the time of importation into the OECD country concerned, is licensed, registered or authorised in that OECD country.

Where explicit consent has been sought pursuant to point (a) of the first subparagraph, if the [F162Designated National Authority] has not received a response to the request within 30 days, the [F162Designated National Authority][F163must] send a reminder [F164to the designated national authority of the importing Party or Northern Ireland or to an appropriate authority in the importing other country]. Where appropriate, if there is still no response within a further 30 days, the [F165Designated National Authority] may send further reminders as necessary.

7.In the case of chemicals listed in Part 2 or 3 of [F166the GB PIC list], the [F167exporter’s Designated National Authority] may, F168... subject to the second subparagraph, decide that the export may proceed, if no evidence from official sources of final regulatory action to ban or severely restrict the use of the chemical taken by the [F169importing Party, other country or Northern Ireland] exists and if, after all reasonable efforts, no response to a request for explicit consent pursuant to point (a) of paragraph 6 has been received within 60 days and where one of the following conditions is met:

(a)there is evidence from official sources in the [F169importing Party, other country or Northern Ireland] that the chemical is licensed, registered or authorised; or

(b)the intended use declared in the export notification and confirmed in writing by the natural or legal person importing the chemical into [F170a Party, other country or Northern Ireland], is not in a category for which the chemical is listed in Part 2 or 3 of [F171the GB PIC list], and there is evidence from official sources that the chemical has in the last five years been used in or imported into the importing Party or other country concerned [F172or used in or imported into Northern Ireland (as appropriate)].

In the case of chemicals listed in Part 3 of [F173the GB PIC list], an export based on the fulfilment of the condition under point (b) may not proceed if the chemical has been classified in accordance with Regulation (EC) No 1272/2008 as carcinogenic category 1A or 1B, or mutagenic category 1A or 1B, or toxic for reproduction category 1A or 1B or the chemical fulfils the criteria of Annex XIII to Regulation (EC) No 1907/2006 for being persistent, bioaccumulative and toxic or very persistent and very bioaccumulative.

When deciding on the export of chemicals listed in Part 3 of [F174the GB PIC list], the [F175exporter’s Designated National Authority] shallF176... consider the possible impact on human health or the environment of the use of the chemical in the [F177importing Party, other country or Northern Ireland]F178....

8.The validity of each explicit consent obtained pursuant to point (a) of paragraph 6 or decision to proceed with export in the absence of explicit consent pursuant to paragraph 7 shall be subject to periodic review by the [F179Designated National Authority] as follows:

(a)for each explicit consent obtained pursuant to point (a) of paragraph 6 a new explicit consent shall be required by the end of the third calendar year after the consent was given, unless the terms of that consent require otherwise;

(b)unless a response to a request has been received in the meantime, each decision to proceed without explicit consent pursuant to paragraph 7 shall be valid for a maximum period of 12 months, upon expiry of which explicit consent shall be required.

In the cases referred to in point (a) of the first subparagraph, exports may, however, continue after the end of the relevant period, pending a response to a new request for explicit consent, for an additional period of 12 months.

F1809.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10.No chemical shall be exported later than six months before its expiry date, where such a date exists or can be inferred from the production date, unless the intrinsic properties of the chemical render that impracticable. In particular, in the case of pesticides, exporters shall ensure that the size and packaging of containers is optimised so as to minimise the risk of creating obsolete stocks.

11.When exporting pesticides, exporters shall ensure that the label contains specific information about storage conditions and storage stability under the climatic conditions of the [F181importing Party, other country or Northern Ireland]. In addition, they shall ensure that the pesticides exported comply with the purity specification laid down in [F182retained EU law].

Textual Amendments

Article 15U.K.Export of certain chemicals and articles

1.Articles shall be subject to the export notification procedure laid down in Article 8 if they contain any of the following:

(a)substances listed in Part 2 or 3 of [F183the GB PIC list] in unreacted form;

(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.

2.Chemicals and articles the use of which is prohibited in [F184Great Britain] for the protection of human health or the environment, as listed in [F185Part 4 or 5 of the GB PIC list], shall not be exported.

Article 16U.K.Information on transit movements

1.Parties to the Convention requiring information concerning transit movements of chemicals subject to the PIC procedure, together with the information requested by each Party to the Convention through the Secretariat, shall be as listed in Annex VI.

2.Where a chemical listed in Part 3 of [F186the GB PIC list] is transported through the territory of a Party to the Convention listed in Annex VI, the exporter shall, as far as practicable, provide the [F187exporter's Designated National Authority] with the information required by the Party to the Convention in accordance with Annex VI no later than 30 days before the first transit movement takes place and no later than eight days before each subsequent transit movement.

F1883.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.The [F189Designated National Authority] shall forward the information received under [F190paragraph 2] to the designated national authorities of Parties to the Convention which requested that information, together with any additional information available, no later than 15 days before the first transit movement and prior to any subsequent transit movement.

Article 17U.K.Information to accompany exported chemicals

1.Chemicals that are intended for export shall be subject to the provisions on packaging and labelling established in, or pursuant to, Regulation (EC) No 1107/2009, [F191Regulation (EU) No 528/2012] and Regulation (EC) No 1272/2008, or any other relevant [F192retained EU law].

The first subparagraph shall apply unless those provisions would conflict with any specific requirements of [F193importing Parties, other countries or Northern Ireland].

2.Where appropriate, the expiry date and the production date of chemicals referred to in paragraph 1 or listed in [F194Part 1, 2 or 3 of the GB PIC list] shall be indicated on the label, and if necessary such expiry dates shall be given for different climate zones.

3.A safety data sheet in accordance with Regulation (EC) No 1907/2006 shall accompany chemicals referred to in paragraph 1 when exported. The exporter shall send such a safety data sheet to each natural or legal person importing the chemical into a [F195Party, other country or Northern Ireland].

4.The information on the label and on the safety data sheet shall as far as practicable be given in the official languages, or in one or more of the principal languages, of the country of destination or of the area of intended use.

Textual Amendments

Article 18U.K.Obligations of the [F196Designated National Authority] for controlling import and export

1.[F197The Designated National Authority] shall have the responsibility of controlling the import and export of chemicals listed in [F198Parts 1, 2 and 3 of the GB PIC list].

[F199The Designated National Authority] shall act in a targeted and coordinated way in monitoring exporters’ compliance with this Regulation.

F2002.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2013.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 19U.K.Further obligations of exporters

1.Exporters of chemicals subject to the obligations set out in Article 8(2) and (4) shall provide the applicable reference identification numbers in their export declaration F202....

2.Exporters of chemicals exempted by Article 8(5) from the obligations set out in paragraphs 2 and 4 of that Article or of chemicals for which those obligations have ceased in accordance with Article 8(6) shall obtain a special reference identification number [F203from the exporter's Designated National Authority] and provide that reference identification number in their export declaration.

F2043.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 20U.K.Exchange of information

1.[F205The Secretary of State] shall, as appropriate, facilitate the provision of scientific, technical, economic and legal information concerning chemicals subject to this Regulation, including toxicological, ecotoxicological and safety information.

[F206The Secretary of State,] shall, as appropriate, ensure the following:

(a)the provision of publicly available information concerning regulatory actions relevant to the objectives of the Convention;

(b)the provision of information for [F207a Party, other country or Northern Ireland] directly or through the Secretariat concerning those actions which substantially restrict one or more uses of a chemical.

2.[F208The Secretary of State and the Designated National Authority] shall protect any confidential information received from [F209a Party, other country or Northern Ireland] as mutually agreed.

3.As regards the transmission of information under this Regulation, and without prejudice to [F210the Environmental Information Regulations 2004 and the Environmental Information (Scotland) Regulations 2004], the following information at least shall not be regarded as confidential:

(a)the information specified in Annex II and Annex IV;

(b)the information contained in safety data sheets referred to in Article 17(3);

(c)the expiry date of a chemical;

(d)the production date of a chemical;

(e)information concerning precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice;

(f)the summary results of toxicological and ecotoxicological tests;

(g)information concerning handling packaging after chemicals have been removed.

4.A compilation of the information transmitted shall be prepared every two years by the [F211Designated National Authority].

Textual Amendments

Article 21U.K.Technical assistance

[F212The Secretary of State] shall, taking into account in particular the needs of developing countries and countries with economies in transition, [F213promote] technical assistance, including training, for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their lifecycles.

In particular, and with a view to enabling those countries to implement the Convention, technical assistance shall be promoted by means of the provision of technical information concerning chemicals, the promotion of the exchange of experts, support for the establishment or maintenance of designated national authorities and the provision of technical expertise for the identification of hazardous pesticide formulations and for the preparation of notifications to the Secretariat.

[F214The Secretary of State] shall actively participate in international activities in capacity-building in chemicals management, by providing information concerning the projects [F215the Secretary of State is] supporting or financing to improve the management of chemicals in developing countries and countries with economies in transition. [F214The Secretary of State] shall also consider giving support to non-governmental organisations.

F216Article 22U.K.Monitoring and reporting

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 23U.K.Updating [F217the GB PIC list]

1.The [F218Secretary of State must review the] list of chemicals in [F219the GB PIC list] at least every year, on the basis of developments in [F220retained EU] law and under the Convention.

2.When determining whether a final regulatory action F221... constitutes a ban or a severe restriction, the effect of that action shall be assessed at the level of the subcategories within the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within any one of the subcategories it shall be included in Part 1 of [F222the GB PIC list].

When determining whether a final regulatory action F221... constitutes a ban or a severe restriction such that the chemical concerned qualifies for PIC notification under Article 11, the effect of that action shall be assessed at the level of the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within either of the categories it shall also be included in Part 2 of [F222the GB PIC list].

3.The [F223Secretary of State must take the] decision to include chemicals in [F224the GB PIC list], or to modify their entry where appropriate, F225... without undue delay.

4.In order to adapt this Regulation to technical progress, the [F226Secretary of State may by regulations amend Annexes II, IV and VI].

[F2275.The function of the Secretary of State under paragraph 3 is subject to the consent requirement in Article 23B.]

Textual Amendments

[F228Article 23AU.K.Regulation making power

1.Any power to make regulations conferred on the Secretary of State by this Regulation is exercisable by statutory instrument.

2.Such regulations may—

(a)contain incidental, supplemental, consequential and transitional provision, and

(b)may make different provision for different purposes.

3.A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.]

[F228Article 23BU.K.The consent requirement

1.Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 and 3.

2.The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998 ) whether or not the exercise of the function also relates to a part of the United Kingdom other than Scotland.

3.The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006 ) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.]

F229Article 24U.K.The budget of the Agency

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 25U.K.Formats and software for submission of information to the Agency

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 26U.K.Exercise of the delegation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 27U.K.Committee procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 28U.K.Penalties

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 29U.K.Transitional period on the classification, labelling and packaging of chemicals

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 30U.K.Repeal

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229Article 31U.K.Entry into force

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F229...

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