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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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Version Superseded: 31/12/2020
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1.The Commission shall immediately forward to the Member States, the Agency and European industry associations 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. It shall also immediately forward to the Member States and the Agency information concerning any cases of failure to transmit a response in accordance with Article 10(2) of the Convention. The Agency shall assign each import decision a reference identification number and keep all information regarding such decisions publicly available by means of the Database, and provide anyone with that information upon request.
2.The Commission shall assign each chemical listed in Annex I a classification in the European Union’s Combined Nomenclature. Those classifications shall be revised as necessary in the light of any changes made in the World Customs Organisation’s Harmonised System Nomenclature or in the European Union’s Combined Nomenclature for the chemicals concerned.
3.Each Member State shall communicate the information and decisions forwarded by the Commission under paragraph 1 to those concerned within its jurisdiction.
4.Exporters shall comply with decisions in each import response no later than six months after the Secretariat first informs the Commission of such decisions under paragraph 1.
5.The Commission, assisted by the Agency, and the Member States 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 Annex I 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 designated national authority of the exporter’s Member State in consultation with the Commission, assisted by the Agency, and the designated national authority of the importing Party or an appropriate authority in an importing other country;
(b)in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the Secretariat pursuant to paragraph 1 indicates that the importing Party has given consent to import.
In the case of chemicals listed in Part 2 of Annex I that are to be exported to OECD countries, the designated national authority of the exporter’s Member State may, at the request of the exporter, in consultation with the Commission and on a case-by-case basis, 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 Agency has not received a response to the request within 30 days, the Agency shall, on behalf of the Commission, send a reminder unless the Commission or the designated national authority of the exporter’s Member State received a response and forwarded it to the Agency. Where appropriate, if there is still no response within a further 30 days, the Agency may send further reminders as necessary.
7.In the case of chemicals listed in Part 2 or 3 of Annex I, the designated national authority of the exporter’s Member State may, in consultation with the Commission assisted by the Agency, on a case-by-case basis and 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 importing Party or other country 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 importing Party or other country 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 a Party or other country, is not in a category for which the chemical is listed in Part 2 or 3 of Annex I, 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.
In the case of chemicals listed in Part 3 of Annex I, 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 Annex I, the designated national authority of the exporter’s Member State shall, in consultation with the Commission assisted by the Agency, consider the possible impact on human health or the environment of the use of the chemical in the importing Party or other country, and submit relevant documentation to the Agency, to be made available by means of the Database.
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 Commission in consultation with the Member States concerned 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.
9.The Agency shall register all requests for explicit consent, responses obtained and decisions to proceed without explicit consent, including the documentation referred to in the third subparagraph of paragraph 7, in the Database. Each explicit consent obtained or decision to proceed without explicit consent shall be assigned a reference identification number and shall be listed with all relevant information concerning any conditions attached, such as validity dates. The non-confidential information shall be made publicly available by means of the Database.
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 importing Party or other country. In addition, they shall ensure that the pesticides exported comply with the purity specification laid down in Union legislation.
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