Official Journal of the European Union

COMMISSION IMPLEMENTING DECISION (EU) 2016/770

of 14 April 2016

establishing a common format for the submission of information concerning the operation of the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals

(notified under document C(2016) 2068)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 22(1) thereof,

After consulting the Committee established by Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (2),

Whereas:

In order to ensure that information provided by the Member States is of a consistent standard, it is appropriate to create a common format to be used by the Member States in fulfilling their reporting obligations under Regulation (EU) No 649/2012.

It is appropriate to specify the exact reporting periods to ensure clarity and consistency as Regulation (EU) No 649/2012 requires Member States to forward the information concerning the operation of the procedures every three years,

HAS ADOPTED THIS DECISION:

Article 1

The common format for submission by the Member States of the information required under Article 22(1) of Regulation (EU) No 649/2012 is set out in the Annex to this Decision.

Article 2

The first report on information to be submitted by the Member States pursuant to Article 22(1) of Regulation (EU) No 649/2012 shall cover the calendar years 2014, 2015 and 2016. The following reports shall cover subsequent three-year periods.

Article 3

This Decision is addressed to the Member States.

Member of the Commission

For the Commission

Done at Brussels, 14 April 2016.

(1) OJ L 201, 27.7.2012, p. 60.

(2) OJ L 396, 30.12.2006, p. 1.

ANNEX

QUESTIONNAIRE

Section 1: General information

1. Which Member State are you reporting for?

2. Primary contact person's name:

3. Please provide an email address for the primary contact person:

4. Reporting period:

Section 2: Information on the designated national authority (Article 4 of Regulation (EU) No 649/2012)

5. How many designated national authorities (DNAs) exist in your Member State?

6. If more than one, could you please specify the distribution of responsibilities between them?

7. What is/are the name(s) of the DNA(s)?

8. Please specify the human resources (in full-time equivalent) in the DNA(s) working on the implementation of the PIC Regulation.

If there are several DNAs please specify the number for each DNA

9. Is/are the DNA(s) also involved in the implementation of other EU/international chemical legislation/convention/programme?

☐ Yes

☐ No

If yes, please specify which legislation/convention/programme and how the coordination with other competent authorities within your country is organised?

10. How many export notifications and special RIN requests have been accepted by the DNA (and forwarded to ECHA for further processing) per year?

Export notifications Special RIN requests Year 1 Year 2 Year 3 Total

Section 3: Support to exporters and importers

11. Have any awareness-raising and information activities been put in place by the DNA(s) to support exporters and importers to comply with the PIC Regulation?

☐ Yes

☐ No

If yes, please specify what these activities are (multiple replies are possible):

☐ Online technical and scientific guidance (other than ECHA's)

☐ Reference to ECHA webpages on PIC and ePIC

☐ Specific web page providing information on the PIC Regulation

☐ Awareness-raising campaign

☐ Social media

☐ Visits to operator establishments

☐ Specific email address for information requirements

☐ National helpdesk

☐ Workshops and similar training events

☐ Others

If others, please specify.

If no, please specify why this support is not required.

12. Do you consider that these awareness-raising and information activities have improved the compliance of exporters and importers with Regulation (EU) No 649/2012?

☐ Yes

☐ No

Please specify.

13. On which matters do(es) the DNA(s) get the two most frequent requests for support coming from exporters and importers? Please select two matters.

☐ Export notification

☐ Explicit consent

☐ Waiver

☐ Special RIN

☐ Article 10 reporting

☐ Others

If others, please specify.

14. Can you estimate the amount of time spent by the DNA(s) on such support?

☐ up to 10 % of workload

☐ 20 % of workload

☐ 30 % of workload

☐ 40 % of workload

☐ more than 40 % of workload

☐ Not quantifiable

Section 4: Coordination between DNAs/ECHA and the Commission

15. Are you satisfied with the coordination between your DNA(s) and the Commission?

☐ Yes

☐ No

Please specify.

16. Please specify the areas of coordination that could be improved, if any (multiple replies are possible).

☐ Article 8(5) — export in case of an emergency situation

☐ Article 8(7) — additional information to be provided on request concerning the exported chemical

☐ Article 11(6) — Member State obligation to assist the Commission in compiling information

☐ Article 11(7) — evaluation of the need to propose measures at Union level

☐ Article 11(8) — procedure in case a Member State takes national final regulatory action

☐ Article 13(6) — evaluation of the need to propose measures at Union level

☐ Article 14(1) — obligation to forward information received from the Secretariat

☐ Article 14(5) — advice and assistance to importing parties upon request

☐ Article 14(6) — Member State decision that no explicit consent is required

☐ Article 14(7) — Member State decision that export may proceed

☐ Article 14(7) — Member State consideration of possible impacts on human health or environment

☐ Article 14(8) — periodic review of the validity of explicit consent

☐ Article 18(1) — Commission, Member State, ECHA obligation to monitor exporter compliance

☐ Article 20 — exchange of information

☐ Article 21 — technical assistance

☐ Article 23 — updating annexes

☐ Other

If other, please specify.

17. Are you satisfied with the coordination between your DNA(s) and ECHA?

☐ Yes

☐ No

Please specify.

18. Please specify the areas of coordination that could be improved, if any (multiple replies are possible).

☐ Article 6(1)(c) — assistance and technical and scientific guidance and tools for the industry

☐ Article 8(7) — additional information to be provided on request concerning the exported chemical

☐ Article 11(6) — Member State obligation to assist the Commission in compiling information

☐ Article 11(7) — evaluation of the need to propose measures at Union level

☐ Article 13(6) — evaluation of the need to propose measures at Union level

☐ Article 20 — exchange of information

☐ Article 21 — technical assistance

☐ Article 23 — updating annexes

☐ Other

If other, please specify.

Section 5: Export notifications forwarded to Parties and other countries

(Only relevant for Member States that processed export notifications in the reporting period.)

19. What are the information requirements requested in the export notification form where exporters have difficulties to provide the information (multiple replies are possible)?

☐ Identity of the substance to be exported

☐ Identity of the mixture to be exported

☐ Identity of the article to be exported

☐ Information concerning the export (e.g. contact details of importers)

☐ Information on hazards or risks of the chemical and precautionary measures

☐ Summary of physico-chemical, toxicological and ecotoxicological properties

☐ Information on the final regulatory action taken by the European Union

☐ Additional information provided by the exporting Party

☐ Availability of CN codes or CUS codes

☐ Intended use of the chemical in the importing country

☐ Summary of and reasons for the final regulatory action and date of entry into force

☐ None

Please provide further comments if needed.

20. What is the number of export notifications sent back to the exporter for the reasons mentioned in the table below?

Reason/Number per year Year 1 Year 2 Year 3 Resubmission requested Rejected

If relevant, please specify the most frequent reasons for requesting re-submission and for rejecting export notifications:

Reasons for requesting resubmission of export notifications:

Reasons for rejecting export notifications:

21. Have you experienced difficulties in complying with the time frame to forward the notifications to ECHA?

☐ Yes

☐ No

If yes, please specify and provide further comments if needed.

Article 8(5) — export of a chemical relating to an emergency situation

22. Have you had to deal with an emergency situation pursuant to Article 8(5)?

☐ Yes

☐ No

If yes, please describe the most important cases (e.g. chemical used, importing country, intended use, nature of the emergency).

23. Have you experienced difficulties in implementing the emergency situation procedure?

☐ Yes

☐ No

☐ No such situation occurred

If yes, please specify.

Article 8(7) — provision of available additional information concerning exported chemicals

24. Were you requested to provide additional information concerning exported chemicals to importing parties and other countries?

☐ Yes

☐ No

If yes, please specify in which cases (e.g. name of chemical, importer contact details, importing country, type of additional information provided).

25. If you received such a request, did you experience any difficulties in providing the additional information?

☐ Yes

☐ No

If yes, please specify.

Article 8(8) — administrative fee for export notifications

26. Do(es) the DNA(s) in your country request an administrative fee for export notifications?

☐ Yes

☐ No

☐ Depends on the DNA.

If the reply depends on the DNA, please specify.

If a fee is requested, please reply to questions 27-30. If not, continue with question 31.

27. How much is this administrative fee (please specify currency if not EUR)?

28. What is the date of entry into force of the administrative fee?

29. Have you received complaints from exporters on the level of administrative fees?

☐ Yes

☐ No

If yes, please specify the type of complaints and their number per year

30. In your view, did the administrative fee have an impact on the number of notifications (optional)?

☐ Yes

☐ No

☐ Do not know.

If yes, please specify.

31. Do(es) the DNA(s) in your country request an administrative fee for requests for explicit consent?

☐ Yes

☐ No

☐ Depends on the DNA.

If the reply depends on the DNA, please specify.

If an administrative fee is requested, please specify the amount (and the currency, if not in EUR).

Section 6: Information on export and import of chemicals

Exporters (Article 10)

32. Have you experienced delays from exporters in the submission of information on 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 reporting period?

☐ Yes

☐ No

☐ Not applicable

If yes, please provide additional comments.

Importers (Article 10)

33. Have you experienced delays from importers in submitting information on the quantity of the chemical, as a substance and as contained in mixtures or in articles, received during the reporting period?

☐ Yes

☐ No

☐ Not applicable

If yes, please provide additional comments.

34. Is the data or information on imports used by the DNA(s), customs or other enforcement authorities in your country?

☐ Yes

☐ No

☐ Do not know

If yes, please specify how it is used.

Member State reporting to ECHA

35. Have you experienced difficulties in reporting through ePIC aggregated information pursuant to Article 10 in conjunction with Annex III?

☐ Yes

☐ No

If yes, please detail the difficulties encountered.

36. Have you experienced delays in submitting aggregated information through ePIC in accordance with Annex III?

☐ Yes

☐ No

If yes, please specify the reasons for these delays.

Section 7: Obligations in relation to export of chemicals other than export notification

Communication of information and decisions to those concerned within the jurisdiction of your Member State (Article 14(3))

37. How did you communicate information on decisions and/or conditions of importing countries to those concerned within the jurisdiction of your Member State (multiple replies are possible)?

☐ Email

☐ Website

☐ Newsletters

☐ Other means

If other means, please specify.

Exporter compliance with decisions in each import response (Article 14(4))

38. Have you experienced problems concerning exporters' compliance with import responses given by Parties?

☐ Yes

☐ No

If yes, please specify.

Provision of support to importing parties (Article 14(5))

39. Have you advised and/or assisted importing Parties, upon request in obtaining further information needed to prepare a response to the Secretariat of the Convention concerning the import of a given chemical?

☐ Yes

☐ No

If yes, please provide further details.

Substances that cannot be exported unless certain conditions are fulfilled (Article 14(6))

40. Have you implemented the explicit consent procedure pursuant to Article 14(6)(a) in the reporting period?

☐ Yes

☐ No

If yes, please specify the number of requests for explicit consent and the number of responses received per year.

Number of requests Number of responses Year 1 Year 2 Year 3 Total

41. Have you implemented the explicit consent procedure pursuant to Article 14(6)(b)?

☐ Yes

☐ No

If yes, please specify the number of special RIN requests per year for which the importing Party has given consent to import through the import response published in the PIC circular.

Year 1 Year 2 Year 3 Total

42. Have you experienced difficulties in implementing the explicit consent procedure?

☐ Yes

☐ No

☐ Not applicable

If yes, please specify.

43. Have you had to decide on whether no explicit consent was required in case of chemicals listed in Part 2 of Annex I to be exported to OECD countries?

☐ Yes

☐ No

☐ Not applicable, since your DNA did not receive any such export notification.

If yes, please specify the number of cases per year.

Year 1 Year 2 Year 3 Total

44. Have you experienced difficulties in taking a decision whether no explicit consent was required in case of chemicals listed in Part 2 of Annex I to be exported to OECD countries?

☐ Yes

☐ No

☐ Not applicable, since no such case occurred.

If yes, please specify.

DNAs decision that export may proceed 60 days after an explicit consent request was made (Article 14(7))

45. Have you received any waiver requests in accordance with Article 14(7)?

☐ Yes

☐ No

☐ Not applicable, since your DNA did not have to make any request for explicit consent.

If yes, please specify the number of cases per year.

Year 1 Year 2 Year 3 Total

46. Have you experienced difficulties in implementing the procedure under Article 14(7)?

☐ Yes

☐ No

☐ Not applicable, since no such case occurred.

If yes, please specify.

Validity of explicit consent (Article 14(8))

47. Have you experienced cases where the export was allowed to proceed pending a reply to a new request for explicit consent pursuant to the second paragraph of Article 14(8)?

☐ Yes

☐ No

☐ Not applicable, since your DNA did not receive any export notification requiring explicit consent.

If yes, please specify their number.

Year 1 Year 2 Year 3 Total

Section 8: Obligations in relation to import of chemicals

Import decisions made available to those concerned (Article 13(5))

48. How are European Union import decisions made available to those concerned within your competence (multiple replies are possible)?

☐ Email

☐ DNA websites

☐ Newsletters

☐ Other means

If other means, please specify.

Section 9: Information on transit movement

First transit movement information and time frame requirements (Article 16)

49. Have you had to implement Article 16 during the reporting period?

☐ Yes

☐ No

If yes, please specify the number of cases, the parties to the Rotterdam Convention involved and the information required

50. Are you aware of any problems experienced by exporters with the implementation of Article 16?

☐ Yes

☐ No

☐ Not applicable, since no such case occurred.

If yes, please specify.

Section 10: Requirements linked to exported chemicals and information to accompany them

51. Have National Enforcement Authorities in your Member State experienced any compliance issues concerning the information to accompany exported chemicals?

☐ Yes

☐ No

☐ Do not know

If yes, please reply to questions 52-54 and specify whether these compliance issues were related to the following:

52. The application of packaging and labelling requirements under:

☐ Regulation (EC) No 1107/2009 of the European Parliament and of the Council (1) (Plant Protection Products — PPP)

☐ Regulation (EU) No 528/2012 of the European Parliament and of the Council (2) (Biocidal Products Regulation — BPR)

☐ Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) (CLP Regulation)

☐ Other

If other, please specify.

53. The application of safety data sheet requirements under:

☐ Regulation (EC) No 1907/2006 (REACH)

☐ Other

If other, please specify.

54. The obligation to give information:

☐ On the label in one or more official/principal languages of the country of destination

☐ On the safety data sheets in one or more official/principal languages of the country of destination

55. Have you experienced any compliance issues concerning the information and packaging requirements linked to the exported products?

☐ Yes

☐ No

☐ Not applicable

If yes, please specify whether these compliance issues were related to:

☐ The application of purity specification under Union legislation (e.g. PPP and BPR)

☐ The optimisation of containers to reduce the risks of creating obsolete stocks

☐ The expiry date

☐ The storage conditions on the label

☐ Others

If others, please specify.

Section 11: Technical assistance (optional)

Cooperation

56. Have you been involved in cooperation with developing countries, countries with economies in transition or non-governmental organisations to improve the proper management of chemicals and in particular to implement the Rotterdam Convention?

☐ Yes

☐ No

If yes, what type of cooperation (multiple replies are possible)?

☐ Technical information

☐ Promotion of the exchange of experts

☐ Support for the establishment or maintenance of DNAs

☐ Technical expertise for the identification of hazardous pesticides formulations

☐ Technical expertise for the preparation of notifications to the Secretariat

☐ Other

If other, please specify.

Please specify the countries benefiting from this cooperation.

Capacity building

57. Have you participated in projects/international activities related to capacity building in chemicals management or supported NGOs involved in such activities?

☐ Yes

☐ No

If yes, please describe these activities.

Section 12: Enforcement of Regulation (EU) No 649/2012

General information

58. Which are the enforcement authorities involved in the enforcement of Regulation (EU) No 649/2012 in your Member State?

☐ Customs

☐ Other enforcement authorities

If other enforcement authorities are involved, please specify.

59. If any, could you please specify which other EU legislation the enforcement authorities (other than customs) are also dealing with:

☐ Regulation (EC) No 1907/2006

☐ Regulation (EC) No 1272/2008

☐ Regulation (EU) No 528/2012

☐ Regulation (EC) No 1107/2009

☐ Other

If other, please specify.

60. Do the enforcement authorities have appropriate resources (optional)?

☐ Yes

☐ No

Please specify.

61. Are inspectors or other persons in charge of enforcement regularly trained on Regulation (EU) No 649/2012?

☐ Yes

☐ No

If yes, please specify (e.g. type of training, topics covered, frequency of training).

If no, please specify why those persons are not regularly trained.

Enforcement strategy

62. Does your authority (or any other relevant authority) have an enforcement strategy for Regulation (EU) No 649/2012?

☐ Yes

☐ No

Please specify as follows:

62(a) If yes, has this enforcement strategy already been implemented?

☐ Yes

☐ No

Please specify.

62(b) If no, are there any plans to develop an enforcement strategy?

☐ Yes

☐ No

Please specify.

Reporting on enforcement activities

63. Please specify the enforcement activities carried out in your Member State (multiple replies are possible).

☐ Conformity checks

☐ On-site visits

☐ Sampling

☐ Others

If others, please specify.

64. Please indicate the total number of official controls on exports, such as inspections or investigations, or other enforcement measures carried out by enforcing authorities in which Regulation (EU) No 649/2012 was covered or enforced during the reporting period.

Customs Inspectors Others Year 1 Year 2 Year 3 Total

Please provide comments, if needed.

65. Please indicate the total number of official controls on imports, such as inspections or investigations, or other enforcement measures carried out by enforcing authorities in which Regulation (EU) No 649/2012 was covered or enforced during the reporting period.

Customs Inspectors Others Year 1 Year 2 Year 3 Total

Please provide comments, if needed.

Power of enforcement authorities

66. Please describe the measures that can be taken by enforcement authorities to ensure compliance with Regulation (EU) No 649/2012 (e.g. seizure, letter of formal notice, suspension of activity).

Details of infringements

67. Number of infringements to Regulation (EU) No 649/2012 observed by:

Customs Inspectors Others Year 1 Year 2 Year 3 Total

68. Type of infringements observed by customs and related numbers per year:

Infringement detected Year 1 Year 2 Year 3 Labelling requirements Safety data sheets Expiry date of the chemical Chemical not in conformity with export notification Others to add in empty rows

69. Type of infringements observed by inspectors and related numbers per year:

Infringement detected Year 1 Year 2 Year 3 Labelling requirements Safety data sheets Expiry date of the chemical Chemical not in conformity with export notification Others to add in empty rows

Penalties

70. Describe the penalties regime in case of infringement of Regulation (EU) No 649/2012 (e.g. criminal/administrative penalties, catch-all provision or specific penalties for specific infringements).

71. How many infringements of Regulation (EU) No 649/2012 have led to penalties during the reporting period?

Number of penalties Year 1 Year 2 Year 3 Total

Collaboration

72. Is there a regular exchange of information between the DNA(s) and enforcement authorities?

☐ Yes

☐ No

Please specify.

73. Do you have any suggestion(s) for improving collaboration between the DNA(s) and enforcement authorities?

74. Is there a regular exchange of information between the DNA(s) and the member(s) of your country of the Forum for Exchange of Information on Enforcement (‘the Forum’)?

☐ Yes

☐ No

Please specify.

75. Is the DNA satisfied with its collaboration with the Forum members?

☐ Yes

☐ No

If no, please provide details.

76. Do you have any suggestion(s) for improving collaboration between the DNA(s) and Forum members?

Role of the Forum for Exchange of Information on Enforcement (‘the Forum’; see Article 18(2))

77. Is the DNA satisfied with the activities carried out by the Forum? (optional)

☐ Yes

☐ No

☐ No experience with the Forum activities

If no, please specify

78. Do you have any suggestion(s) for improving the activities of the Forum with regard to the enforcement of Regulation (EU) No 649/2012 (optional)?

Section 13: IT related aspects

DNAs and the ePIC system

79. Is the ePIC system easy to use for DNAs, in particular when dealing with:

(a) Export notifications (Article 8)? ☐ Yes ☐ No ☐ No experience If no, please specify the problem(s) encountered.

(b) Requests for explicit consent (Article 14)? ☐ Yes ☐ No ☐ No experience If no, please specify the problem(s) encountered.

(c) Special RIN requests (Article 19(2))? ☐ Yes ☐ No ☐ No experience If no, please specify the problem(s) encountered.

(d) Waivers (Article 14 (6) and (7))? ☐ Yes ☐ No ☐ No experience If no, please specify the problem(s) encountered.

(e) Reporting pursuant to Article 10? ☐ Yes ☐ No If no, please specify the problem(s) encountered.

(f) Other PIC procedures? ☐ Yes ☐ No ☐ No experience Please specify the nature of the procedure and the problem(s) encountered, if any.

Exporters and the ePIC system

80. Where possible, please provide feedback from exporters on the user-friendliness of the ePIC system for (optional):

(a) Export notifications ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

(b) Special RIN requests ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

(c) Waivers (Article 14(6) and (7)) ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

(d) Article 10 Reporting ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

(e) Management of mixtures/articles via ePIC ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

(f) The ePIC system in general ☐ Easy to use ☐ Not easy to use If not easy to use, please specify the problem(s) encountered.

Customs, other enforcement authorities and the ePIC system (optional)

81. Are customs authorities in your country using the ePIC system?

☐ Yes

☐ No

If not, please explain how exports of PIC chemicals are monitored by customs authorities in your country.

82. To your knowledge, do customs consider that the ePIC system is easy to use?

☐ Yes

☐ No

☐ No information available

83. To your knowledge, do customs consider that the ePIC system is an adequate tool to support them in controlling the application of Regulation (EU) No 649/2012?

☐ Yes

☐ No

☐ No information available

84. To your knowledge, are other enforcement authorities using the ePIC system?

☐ Yes

☐ No

☐ No information available

85. To your knowledge, do these other enforcement authorities consider that the ePIC system is easy to use?

☐ Yes

☐ No

☐ No information available

86. To your knowledge, do these other enforcement authorities consider that the ePIC system is an adequate tool to control the application of Regulation (EU) No 649/2012?

☐ Yes

☐ No

☐ No information available

Section 14: Additional comments

87. Please provide any other information or comments related to the operation of the procedures under Regulation (EU) No 649/2012 that you consider relevant within the framework of the reporting pursuant to Article 22.

(1) 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 and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(2) Regulation (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 (OJ L 167, 27.6.2012, p. 1).

(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).