EUROPEAN COMMISSION

Brussels, 13.9.2022

SWD(2022) 218 final

COMMISSION STAFF WORKING DOCUMENT

Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals

Accompanying the document

Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions

Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals

{COM(2022) 412 final}

Table of Contents

1Introduction

1.1The PIC Regulation

1.2The reporting exercise

1.3Methodology

1.3.1Preparation of the Commission’s report

1.3.2Implementation of the common format for reporting for Member States in the form of a web-based questionnaire

1.3.3Synthesis of Member States’ reporting

1.3.4Drafting the synthesis report and summary

2Governance of the PIC Regulation

2.1Organisation of the implementation of the PIC Regulation

2.1.1European Commission

2.1.2European Chemicals Agency (ECHA)

2.1.3DNAs

2.2Coordination between the Commission, the Agency and Designated National Authorities

2.2.1Coordination between DNAs and the Commission

2.2.2Coordination between DNAs and the Agency

2.2.3Coordination between the Agency and the Commission

2.3The EU as a Party to the Rotterdam Convention

2.3.1Coordination of Union input to the Conference of the Parties (CoP)

2.3.2Participation in committees and expert groups

2.3.3Financial contributions to the Rotterdam Convention

3Updates of Annex I and Annex V to the PIC Regulation

3.1Update of Annex I

3.2Updates of Annex V

4Operation of the PIC Regulation

4.1Support to exporters and importers

4.1.1Support provided by DNAs

4.1.2Support provided by the Agency

4.2Export notifications sent to Parties and other countries (Article 8)

4.2.1Export notifications processed during the reporting period

4.2.2Special RIN requests processed during the reporting period

4.2.3Requests for resubmission and rejection of export notifications

4.2.4Difficulties encountered in the export notification procedure

4.2.5Emergency situations (Article 8(5))

4.2.6Provision of available additional information on exported chemicals

4.2.7Administrative fee for export notifications

4.3Export notifications from Parties and other countries (Article 9)

4.4Information on export and import of chemicals (Article 10)

4.5Notification of banned or severely restricted chemicals under the Convention (Article 11-12)

4.6Obligations in relation to importing chemicals (Article 13)

4.7Obligations in relation to exports of chemicals, other than export notifications (Article 14)

4.7.1Communication of information and decisions to those concerned within the jurisdiction of a Member State (Article 14(3))

4.7.2Explicit consent (Article 14(6))

4.7.3Waivers (Article 14(6) and (7))

4.7.4Validity of explicit consent (Article 14(8))

4.8Information on transit movement (Article 16)

4.9Requirements linked to exported chemicals and accompanying information (Article 17)

4.10Enforcement of the PIC Regulation (Article 18)

4.10.1National enforcement authorities (NEAs)

4.10.2Training inspectors

4.10.3Enforcement strategy

4.10.4Enforcement activities

4.10.5Powers of enforcement authorities

4.10.6Infringements during the reporting period

4.10.7Penalties

4.10.8Collaboration between DNAs and NEAs

4.10.9Forum activities

4.11Exchange of information (Article 20)

4.12Technical assistance (Article 21)

4.13IT-related aspects

4.13.1The ePIC system

4.13.2User-friendliness of the ePIC system

4.13.3Areas of improvement

4.13.4Data dissemination

Abbreviations used

BPR        Biocidal Products Regulation

CLP        Classification, Labelling and Packaging Regulation

CN        Combined Nomenclature

CoP        Conference of the Parties to the Rotterdam Convention

CRC        Chemical Review Committee of the Rotterdam Convention

CUS        Customs Union and Statistics

DNA        Designated National Authority

ECHA        European Chemicals Agency

ePIC        Software application for implementation of Regulation (EU) No 649/2012

EU        European Union

FRA        Final Regulatory Action

NEA        National Enforcement Authority

OECD        Organisation for Economic Cooperation and Development

PIC        Prior Informed Consent

POPs        Persistent Organic Pollutants

PPPR        Plant Protection Products Regulation

REACH    Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation

RIN        Reference Identification Number

SDS        Safety Data Sheet 

WPIEI    Council Working Party on International Environmental Issues (Chemicals/Synergies)

1Introduction 

1.1The PIC Regulation 

Regulation (EU) No 649/2012 1 (‘the PIC Regulation’) implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, adopted in 1998 and ratified by the EU in 2002. The Regulation aims to promote shared responsibility and cooperation in the international movement of hazardous chemicals, and to protect human health and the environment from potential harm by facilitating the exchange of information concerning the characteristics of hazardous chemicals, providing for a decision-making process within the EU on the import and export of such chemicals, and disseminating decisions to Parties to the Convention and other countries (Article 1).

The PIC Regulation applies to chemicals subject to the PIC procedure under the Rotterdam Convention, as well as to industrial chemicals (used by professionals and consumers) and pesticides (including biocides) that are banned or severely restricted by EU legislation for health or environmental reasons. It goes beyond the requirements of the Convention since it applies to exports to all countries and requires the consent of the importing country for many more chemicals than those listed under the Convention. In addition, the requirements for export also apply to certain mixtures containing listed chemicals.

Under the PIC Regulation, exports are subject to different requirements depending on their listing in Annex I: chemicals listed in Part 1 of Annex I are subject to export notification to the importing country; chemicals listed in Parts 2 and 3 of Annex I are subject to export notification and explicit consent of the importing country, unless they are subject to the PIC procedure under the Convention and exported to a Party that has provided a positive import response. These obligations also apply to mixtures containing substances listed in Annex I to the Regulation in concentrations that trigger labelling obligations under the Classification, Labelling and Packaging Regulation (EC) No 1272/2008 2 (CLP Regulation), and to articles containing substances listed in Parts 2 or 3 of Annex I in unreacted form, or mixtures containing substances listed in Parts 2 or 3 of Annex I in concentrations that trigger labelling obligations under the CLP Regulation.

The PIC Regulation also places obligations on the Commission to notify the Secretariat of the Convention of Final Regulatory Action (FRA) on chemicals that are banned or severely restricted through FRA in the EU in one use category of the Convention (industrial chemicals or pesticides) and which are listed in Part 2 of Annex I of the PIC Regulation, as well as to inform other Parties about their potential risks and allow them to consider whether or not risk management measures are needed in their own territories. This process is known as the FRA notification and is the basis for the listing of chemicals in Annex III to the Convention.

For chemicals that are listed in Part 3 of Annex I (which reflects Annex III to the Convention), the Commission, on behalf of the Union and based on the empowerment in the PIC Regulation, establishes an import decision that outlines whether and under which conditions the chemical can be imported in the Union. This import decision is sent to the Secretariat of the Convention.

1.2The reporting exercise 

Article 22 of the PIC Regulation requires the Commission to report on its activities under the Regulation every three years, and to compile a synthesis report on the performance of the PIC Regulation, integrating the following:

·The information submitted by Member States as per Article 22(1), concerning the operation of the procedures provided for in this Regulation, including customs’ controls, infringements, penalties and remedial action.

·The information submitted by the European Chemicals Agency (ECHA) as per Article 22(1), concerning the operation of the PIC Regulation’s procedures.

This reporting exercise is the second under the PIC Regulation and covers the period 2017-2019. The questionnaire follows, as in the first reporting exercise, the common reporting format for Designated National Authorities (DNAs), which was established by Commission Implementing Decision (EU) 2016/770 of 14 April 2016 3 . The reporting questionnaire was however slightly revised to improve the user-friendliness of the questionnaire and the clarity of some of the questions. The online reporting questionnaire was made available to the Member States on 9 June 2021, with a deadline for completion set to 27 August 2021. All reports were submitted by mid-November 2021. The Agency published its report on the operation of the PIC Regulation 4 for the period 2017-2019 in August 2020.

The present report is the synthesis report (as per Article 22 of the PIC Regulation), bringing together the findings from the reports of the Commission, the Agency and Member States. It provides an overview of the implementation of the PIC Regulation in the period 2017-2019.

1.3Methodology

1.3.1Preparation of the Commission’s report

The Commission’s report, available in Annex III, is divided into two sections, the first section presenting the work of the Commission with respect to the implementation of the Regulation within the EU, and the second section presenting the international work of the Commission as the EU DNA to the Rotterdam Convention, during the period 2017-2019.

To prepare this report, relevant information was compiled from EUR-Lex, the websites of the Rotterdam Convention and ECHA, and documents published on CIRCABC, including minutes of meetings, and other documents discussed at DNA meetings ( Table 1 ). Other information was obtained first-hand from Commission officials. This report was then used as a source for the synthesis report.

Table 1: List of relevant documents consulted for the Commission report

1.3.2Implementation of the common format for reporting for Member States in the form of a web-based questionnaire

Before the launch of the questionnaire, the consultant reviewed the questionnaire with a view to increase its clarity and usability for DNAs. As the reporting format had been adopted through a Commission Implementing Decision, most changes were limited to improving the format or wording of the questions, add clarifications, definitions and guidance where needed etc. The focus of the revision concerned in particular questions for which it was identified in the previous reporting that Members had difficulty to answer, did not provide all expected information or provided inconsistent information. In the section on enforcement of the PIC Regulation, one question on infringements was also amended based on the work carried out by the Forum during the reporting period 5 . A summary of the changes made to the questionnaire is available in Annex V. 

The common reporting format was made available online to Member States on 9 June 2021, through EU Survey. A guidance document for Member States accompanied the invitation email.

To facilitate Member State reporting, the Agency has made data from ePIC available to DNAs for the following questions:

·Section 2 - Question 10: number of export notifications and Special RIN requests accepted by DNA and forwarded to the Agency. 

·Section 5 - Question 20: number of export notifications sent back to the exporter either to request resubmission or because the notification was rejected. 

·Section 7 - Question 40: number of requests for explicit consent and number of responses received per year.

·Section 7 - Question 43: number of cases where DNA had to decide if no explicit consent was required in case of chemicals listed in Part 2 of Annex I to be exported to OECD countries.

·Section 7 - Question 45: number of waiver requests received by DNAs. 

·Section 7 - Question 47: number of cases where the export was allowed to proceed pending a reply to a new request for explicit consent. 

For consistency, the data provided by the Agency were used for these questions, even where the data provided by the Member States differed from that data sent by the Agency.

1.3.3Synthesis of Member States’ reporting 

Once all Member States had returned their reporting questionnaires, the full dataset and statistics were downloaded in excel format from EU Survey. The information provided by the DNAs was compiled and summarised for each question and presented visually, where relevant. The synthesis of the Member States’ reports is available in Annex IV.

1.3.4Drafting the synthesis report and summary 

The synthesis report combines the information from the Commission report, the Member States’ reporting questionnaires and the Agency’s questionnaire. It follows the structure of the common Member States’ reporting questionnaire and the questionnaire for the Agency’s reporting, integrating the information from the Commission report, where relevant. The summary, available in Annex II, follows the same structure as that of the synthesis report, presenting the key facts and conclusions from each section.

2Governance of the PIC Regulation 

2.1Organisation of the implementation of the PIC Regulation 

2.1.1European Commission 

The Commission, in cooperation with the Member States, is responsible for policy work under the PIC Regulation, in particular the adoption of amendments to Annexes I and V to the Regulation. In addition, the Commission is responsible for the legal interpretation of the Regulation, and the representation of the Union at the Convention and towards non-EU Parties, which includes acting as a common designated authority for the administrative functions of the Convention with respect to the PIC procedure (see Section 2.3). The Commission also chairs the DNA meetings that occur twice a year, normally in April and October.

DG Environment is in charge of the PIC Regulation. Unit B.2 – safe and sustainable chemicals has one policy coordinator responsible for carrying out the Commission’s administrative functions under PIC. The policy coordinator is supported by a policy officer, a lawyer for legal questions and by a secretary for all organisational work. For international work, Unit B.2 had two experts (the policy coordinator and a policy officer) nominated to the Convention bodies, i.e. the CRC and the intersessional working group on the process of listing chemicals in Annex III to the Convention. In addition, colleagues of Unit F.2 (bilateral and regional environmental cooperation) contributed to the technical assistance contracts on implementation of the Rotterdam Convention and F.3, responsible for multilateral environmental cooperation, contributed to the international work, in particular in the context of the Conference of the Parties (CoP), by dealing with horizontal and cross-cutting matters, such as financial resources, budget, technical assistance and some legal matters. The staff resources occupied by this work amount to 0.4 FTE for the policy coordinator, 0.3 FTE for policy officer/legal officer, and 0.1 FTE for the supporting work, including international matters.

2.1.2European Chemicals Agency (ECHA)

The Agency plays a central role in ensuring that the export notification procedure functions properly, as well as developing and operating the application to process export notifications and the explicit consent given by the importing countries (ePIC). More specifically, the tasks of the Agency include:

·Registering the export notifications established by the exporters and sent by EU DNAs, assigning them a Reference Identification Number (RIN), checking their completeness and forwarding them to the DNA of the importing country (Article 8(2).

·Sending a second export notification if the Agency does not receive an acknowledgement of receipt from the authority in the importing country within 30 days of the first notice (Article 8(3)).

·Making available to all EU DNAs export notifications received from non-EU country DNAs (Article 9(1)).

·Acknowledging receipt of export notifications received from non-EU countries (Article 9(1)).

·Sending a reminder for an explicit consent request if no response is received from the importing country within 30 days of the initial request; sending a second reminder after a further 30 days if a response is still outstanding (Article 14(6)).

·Managing ePIC and keeping all relevant documents available on the platform;

·Supporting the EU DNAs and the European Commission in assessing waivers pursuant to Article 14(6) and 14(7).

·Aggregating and summarising the data received each year from DNAs on the quantities of exported and imported chemicals, and making non-confidential information publicly available (Article 10(3)).

·Every two years, compiling and publishing the information transmitted by the Commission, the Member States and the Agency to the authorities in non-EU countries on the chemicals subject to the Regulation.

·The Agency’s Secretariat of the Forum for Exchange of Information on Enforcement established by the REACH Regulation also provides coordination and support to discussions related to PIC (Article 18(2)).

·Participate in the twice-yearly DNA meetings organised by the Commission and provide updates on the operations and contribute to the discussions at these meetings.

In addition, the Agency provides assistance and technical and scientific guidance to industry, the DNAs from Member States and non-EU countries, and the European Commission (Article 6).

Resources dedicated by the Agency to the operation of the PIC Regulation have remained stable over the reporting period ( Table 2 ). Compared to the previous reporting period, ECHA has dedicated slightly more resources to the PIC Regulation during this reporting period (i.e. 8 FTEs compared to 7 FTEs in 2014-2016).

Table 2: Agency’s staff working on the PIC Regulation

The Agency’s staff working on PIC also collaborate with the staff working on other EU regulations for which the Agency is responsible, i.e. REACH, CLP and the Biocidal Products Regulation (BPR), where there are synergies with processes that run across the various pieces of legislation. For example, the Agency’s staff collaborate on:

·Scientific, technical and regulatory support including:

ochecking the identification of substances to be added to the PIC Regulation,

ochecking compliance of Safety Data Sheets (SDS),

ochecking the application of CLP rules,

ochecking the regulatory status and background of substances under BPR or REACH,

odrafting Final Regulatory Action (FRA) notifications for the Rotterdam Convention Secretariat, in support to the Commission,

ohaving a member of the Agency nominated at the Chemical Review Committee (CRC) of the Rotterdam Convention,

oproviding support to stakeholders (including through the Helpdesk, the publication/update of various manuals, guidelines and factsheets, and communication actions, ECHA Newsletter, social media, etc.).

·Development and maintenance of ePIC in order to benefit from synergies between all the Agency’s IT tools concerning login and account management;

·Making available of PIC data (dissemination);

·Planning, data mining and reporting (i.e. optimise the planning and reporting of ECHA’s activities across the various legislations and activities);

·Legal advice;

·Human resources and finance.

The Agency’s workload during the reporting period was in line with the predicted workload. As highlighted in the Agency’s report, the number of export notifications processed has continued to increase over the whole reporting period, in line with the predicted 10% yearly increase ( Table 3 ). The situation contrasts with the previous reporting period, where the Agency had reported that the number of export notifications had increased beyond the expected 10% annually.

However, the continued increase in export notification has led, as in the previous reporting period, to an increase in processing tasks to be performed by the Agency and in stakeholder support (e.g. supporting DNAs or responding to requests for clarification/additional information received from authorities in non-EU countries). Support provided by the Agency to the Commission, EU- and non-EU DNAs has taken approximately 30-40% of staff time during the reporting period ( Table 4 ). This proportion is similar to what was reported for the period 2014-2016.

Table 3: No. of export notifications predicted vs. processed by the Agency

Table 4: No. of requests for technical/regulatory support from the Agency

The Agency has also dedicated human and financial resources to the enhancement of the ePIC application and in the automation of certain processes (to enable industry users and authorities to cope with a higher workload and meet their legal obligations). As in the previous reporting period, IT development remains a resource intensive part of the Agency’s work on the PIC Regulation.

To cope with the uneven distribution of work during the calendar year (with a peak of export notification submissions during the winter months – October to January – which can make up for up to 70 % of the total yearly submissions), the Agency reported hiring interim staff for several months every year during the peak period. This situation was similar already in the previous reporting period.

The budget of the Agency for the operation of the PIC Regulation consists of a subsidy granted by the EU for the purposes of this Regulation. According to Article 24(3), the Commission must examine whether it is appropriate for the Agency to charge a fee for the services provided to exporters and, if so, submit a proposal. The Commission tendered a study in 2019 to fulfil this obligation. The study analysed the implementation of fee systems used by DNAs, analysed the costs of the different services provided by ECHA under the PIC Regulation and developed several options for a fee system, including an assessment of the financial and technical feasibility and appropriateness of the options for the different stakeholder groups impacted (ECHA, exporters, and DNAs), as well as of potential impacts on the overall implementation of the PIC Regulation and on trade. The study was completed in June 2020.

2.1.3DNAs 

Member States play a major role in the application, implementation, and enforcement of the PIC Regulation. As per Article 4 of the PIC Regulation, Member States must designate one or several authorities to carry out the administrative functions required by the Regulation. A total of 38 authorities have been designated by Member States. Article 18 of the PIC Regulation also requires Member States to designate enforcement authorities, such as customs authorities (see Section 4.10).

The responsibilities of the Member States are largely performed by DNAs and can be divided in four categories: administrative tasks, enforcement, monitoring and reporting, and exchange of information 6 .

Administrative tasks

·Check compliance of export notifications with Annex II and forward these to the Agency (Article 8(2)).

·Request explicit consent from the DNA/appropriate authority of the importing country for the export of the chemicals listed in Parts 2 and 3 of Annex I. In the case of export of Annex I Part 2 chemicals to OECD countries, decide (in consultation with the Commission) if the requirement for explicit consent may be waived on the basis of the chemical being licensed, registered or authorised in the OECD country concerned (Article 14(6)). 

·Consult the Commission and take decisions on the granting of a waiver for the export of chemicals listed in Parts 2 and 3 of Annex I in cases where no response is received within 60 days of a request for explicit consent (Article 14(7)). 

·Assist the Commission in its periodic review of explicit consents and waivers (Article 14(8)). 

·Forward export notifications received from third countries to the Agency (Article 9 (2)).

·Provide the Commission with sufficient information on FRA to ban or severely restrict a chemical at national level and consider any comments received from other Member States (Article 11(8)).

·Inform the Commission of national regulatory actions related to PIC chemicals so that this information can be taken into account in EU import decisions (Article 13(2)) and make EU import decisions available to those concerned within their competence (Article 13(5)).

·Forward information on chemicals subject to the PIC procedure and on decisions of importing parties regarding import conditions applicable to those chemicals to those concerned within its jurisdiction (Article 14(3) in conjunction with Article 14(1)).

·Handle Special RIN requests.

·Participate in twice-yearly DNA meetings organised by the Commission, and provide opinions on relevant documents discussed at these meetings.

Enforcement

·Ensure that exporters meet their obligations, in particular those relating to Articles 8, 10, 14, 15 and 17.

·Take measures to ensure compliance, including the establishment of penalties for infringements (Article 28).

·Participate in the activities of the Forum for Exchange of Information on Enforcement related to the PIC Regulation (Article 18(2)).

Monitoring and reporting

·Provide the Agency with annual aggregated reports on trade in chemicals listed in Annex I (Article 10(3)).

·Every three years, provide the Commission with information on the operation of the PIC Regulation (Article 22).

Provision and exchange of information

·Provide importing countries with additional information relating to exported chemicals, on request (Article 8(7)).

·Assist the Commission in compiling additional information with respect to FRA notifications, on request (Article 11(6)).

·Where requested, advise and assist importing countries to obtain additional information to help them with an import response for PIC chemicals (Article 14(5)).

·Forward to the Commission (with a copy to the Agency) any information required by an importing Party to the Convention that has been provided by the exporter concerned prior to each transit movement of a chemical listed in Part 3 of Annex I (Article 16(3)).

·Facilitate the exchange of information (Article 20) and cooperate in the promotion of technical assistance (Article 21).

Most Member States (20) have only one DNA, while 8 have 2 or 3. DNAs are mostly Ministries or agencies responsible for environment, chemicals, and health or health and safety. In a few cases, Ministries responsible for economy, competition, consumption, labour or agriculture have been designated as competent authorities. Since the previous reporting exercise, two Member States have designated new DNAs (the Netherlands and Italy).

In five Member States (out of eight) that have more than one DNA, responsibilities are divided between one DNA responsible for industrial chemicals and one DNA responsible for pesticides. In other cases, there is one main DNA responsible for the implementation of the Regulation (and in some cases delegated tasks to another authority). Table 5 provides information on the distribution of responsibilities in Member States with several DNAs.

Table 5: Distribution of responsibilities across DNAs in Member States with more than one DNA

Germany indicated that they have one DNA for the implementation of the PIC Regulation, but that regarding the Rotterdam Convention, there are two DNAs, one for pesticides and one for industrial chemicals.

PIC DNAs in all Member States are involved in the implementation of other EU or international chemicals legislation, convention or other instrument ( Figure 1 ). Nineteen DNAs are also responsible for the implementation of the REACH Regulation, 17 DNAs for the CLP Regulation, 12 for the POPs Regulation, 15 for the BPR, 8 for the PPPR and 8 for the Detergents Regulation. In 13 Member States, the PIC DNAs are also involved in the implementation of the Basel, Rotterdam and Stockholm (BRS) Conventions.

Figure 1: Other EU legislation for which PIC DNAs are also responsible

PIC DNAs reported levels of resources dedicated to the implementation of the PIC Regulation ranging from 0.1 to 2 FTEs. To the extent that comparison is possible (as some DNAs have reported resources in different units in both periods), resources have remained quite stable in many DNAs, with around eight reporting a decrease.

2.2Coordination between the Commission, the Agency and Designated National Authorities

2.2.1Coordination between DNAs and the Commission 

As in the previous reporting exercise, all Member States considered the coordination between the DNAs and the Commission to be satisfactory. Member States mentioned that the support provided by the Commission to DNAs (especially answers to DNA questions) is quick and of good quality.

The main areas of improvement, according to DNAs, are, as in the previous reporting, the obligation to monitor exporters’ compliance, shared by the Commission, the Agency and the DNAs (Article 18(1)) and the update of annexes (Article 23) – although fewer Member States mentioned those as areas to be improved compared to the period 2014-2016. Over half of the DNAs (15) replied that none of the proposed areas of coordination (listed in the question 7 ) need to be improved.

For its part, the Commission also considered the cooperation with DNAs to be satisfactory. There have been regular exchanges during the reporting period on scientific, technical and legal questions arising in the context of implementation, in particular through discussions at the twice-yearly PIC DNA meetings. The Commission also coordinates and consults with DNAs on any submissions to the Secretariat of the Rotterdam Convention.

2.2.2Coordination between DNAs and the Agency 

As in the previous reporting exercise all Member States considered the coordination between the DNAs and the Agency to be satisfactory. Member States mentioned that the assistance provided by the Agency to DNAs is appreciated for its swiftness and quality – quick responses to questions, informal exchanges when needed, support on specific issues when raised, information about updated tools or guidance.

DNAs generally considered that none of the proposed areas of coordination (listed in the question 8 ) required improvements. Areas that were flagged by DNAs as needing improvements in the previous reporting exercise – Article 23, Article 21 and Article 8(7) – are this time only flagged by one or two Member States.

According to the Agency, ECHA and the DNAs work together in a collaborative, efficient and friendly manner, and differences of views are discussed and solved easily. An illustration of the good cooperation, according to the Agency, is the one-day visit to ECHA of a small German DNA delegation in September 2019 as this allowed the teams to know each other better, to exchange on the respective working approaches and methods, and to discuss some specific issues that were more difficult to address in written communication. According to the Agency, it would be useful to replicate such visits with other Member States.

However, the Agency indicated that there are areas in which the collaboration could be smoother and more efficient. Those areas include the implementation of Article 8(2) on the timelines for processing export notifications, Article 8(5) on export in case of an emergency situation, Article 14(6) on substances that cannot be exported unless certain conditions are fulfilled, and Article 14(6) and (7) on decisions that the export can proceed in the absence of an explicit consent. Those areas of improvements are the same as those mentioned in the previous Agency’s report for the period 2014-2016.

2.2.3Coordination between the Agency and the Commission 

The Commission considered cooperation with the Agency to be satisfactory, as there were regular exchanges on scientific, technical and legal questions arising in the context of implementation, in particular on the legal interpretation of provisions and their practical implementation. The Agency participated in all DNA meetings to report on the work done in the area of implementation. The Commission contributed to the development of information sheets produced by the Agency (for instance, the information sheet on waivers 9 ) and to the work of the Forum on Exchange of Information on Enforcement, in particular to the pilot project on the control of PIC duties, carried out by the Forum in 2018 10 .The Commission contributed to the project manual drafted by the Forum, which was then used by Member States for implementation of the project.

Regarding the cooperation with non-EU countries and the Secretariat of the Rotterdam Convention, the Commission and the Agency have closely coordinated their activities to ensure that the most appropriate and effective assistance is provided and that resources are used efficiently.

As in the previous reporting period, the Agency indicated that the coordination with the Commission is generally satisfactory. The Agency welcomed the establishment of more regular contacts between the Agency’s PIC Operations Team and the Commission, such as regular teleconferences, every six weeks in average, to discuss ECHA’s PIC-related tasks/activities. The Agency indicated that those teleconferences could be usefully complemented by more regular and informal contacts.

The Agency however indicated that coordination and cooperation with the Commission could be improved in some areas:

·Preparation of FRA notifications to the Rotterdam Convention Secretariat: According to the Agency, the regular teleconferences have improved the predictability and planning of this work. However, the planning of the work could be further improved and the efficiency could be increased by agreeing on near-term deadlines for the Commission to provide comments on notifications drafted by ECHA.

·Technical preparation of meetings: Regarding PIC DNA meetings, the Agency indicated that there is potential for better planning and stronger collaboration in the identification of agenda items, the preparations of the discussions and the development of the related supporting meeting documents. This would both help the Commission make the most of ECHA’s insights and support a better planning and use of the Agency’s resources. The need for stronger collaboration in the preparation of DNA meetings was already highlighted by the Agency in its previous report. Regarding their participation in the Chemical Review Committee meetings (i.e. ECHA provided an expert from mid-2017 to mid-2019 to the member seat of the United Kingdom), the Agency highlighted the good cooperation between ECHA, the Commission, other EU participants and other CRC members, but noted that the workload was higher than estimated and than initially agreed between the Commission and ECHA.

·Article 14(6) and (7) on decisions that the export can proceed in the absence of an explicit consent: regarding this process, the Agency makes a similar point as in the previous report. The final check performed by ECHA at the time of the activation of the related export notification leads in certain cases (circa 20 cases per year in the reporting period) to the revision of the initial decision, which in turn often triggers requests for clarification addressed to ECHA by the exporters due to the delay in the activation of the export notification. According to ECHA, the processing of waiver proposals may be delayed due to limited resources at the Commission to perform the task, while ECHA would have the capacity to process them within a maximum of 2 working days. The Agency considers that it would simplify the procedure and improve the overall efficiency of the waivers process, if the Agency played an earlier and enhanced role in the waiver approval process.

·Article 23 on updating annexes: The Agency is now involved at an earlier stage in the process of amending the Annexes I and V to the PIC Regulation, which was a request from the Agency in the previous reporting period. The Agency considers this change has been valuable both in ensuring consistency in substance identification and improving planning. According to the Agency, it could however support further the Commission, in particular with regards to the prioritization of candidate substances for their inclusion in Annex I (and Annex V) to the PIC Regulation. The Agency proposes to work with the Commission to investigate how ECHA could most appropriately support the Commission in that area. ECHA also recommends that it becomes standard practice to adopt amendments to Annex I (and Annex V) early in the year so that they enter into force before the end-of-year annual export notifications’ submission peak. This was done during this reporting period and reduced the burden on all actors.

·Day-to-day exchanges between the Agency and the Commission: The Agency recommends that the Commission establishes a proper backing-up system to ensure that ECHA can reach a PIC contact at the Commission, and ensure a smooth running of PIC operations, at all times, including in the summer period, during which the PIC operations continue (and may sometimes see increased workload due to e.g. the entry into application of an amendment to the list of substances subject to PIC).

2.3The EU as a Party to the Rotterdam Convention 

The Commission, as the EU DNA, is the main interface with the Secretariat of the Convention. In particular, the Commission is responsible for:

·Representation of the EU to the Rotterdam Convention. 

·Coordination of EU input on all technical issues related to the Convention, the preparation of the CoP, the CRC and other subsidiary bodies of the CoP.

·Submission to the Secretariat of relevant FRA notifications concerning chemicals qualifying for PIC notification. 

·Transmission of information on other FRA involving chemicals not qualifying for PIC notification. 

·Submission to the Secretariat of EU import responses for chemicals subject to the PIC procedure.

·Exchange of information with the Secretariat in general. 

The Member States, as Parties to the Convention, also participate in the CoP, the CRC and activities under the Convention, such as the intersessional working group on the process of listing chemicals in Annex III to the Convention. The Member States and their DNAs provide input to the EU position on matters discussed at the CoP. Some DNAs also participate in technical assistance activities under the Convention, to which the Agency also contributes.

2.3.1Coordination of Union input to the Conference of the Parties (CoP)

During the reporting period, the 8th Conference of the Parties to the Rotterdam Convention took place from 24 April to 05 May 2017, and the 9th CoP, from 29 April to 10 May 2019.

CoP-8 (24 April to 05 May 2017)

Replying to an invitation of the Secretariat, the Commission submitted comments on behalf of the European Union on the listing in Annex III of chemicals that had been recommended by the CRC for listing. Those comments were agreed in WPIEI before their submission.

The Commission contributed to the drafting of EU and its Member States comments on amendments proposed by other Parties, i.e. the proposals to amend Articles 16 and 22 of the Convention. Those comments were agreed in WPIEI and submitted to the Secretariat on behalf of the EU and its Member States.

Before the CoP, the Commission prepared a proposal for a Council Decision establishing the position to be adopted on behalf of the European Union within the Conference of the Parties with regard to amendments of Annex III to the Rotterdam Convention (COM(2017) 73 final), to get the mandate for the participation in the decision-making at the CoP. The proposal was submitted to the Council in February 2017 and adopted on 3 April 2017.

In addition, the Commission contributed to the drafting of the position papers of the EU and its Member States and to the corresponding statements for their participation in the CoP. The position papers and statements cover all agenda items of the meeting.

Before the 8th meeting of the CoP, the Commission also consulted DNAs on the possibility to organise meetings at the 8th Conference of the Parties between the European Union, Member States, and other Parties, following the positive experience of such meetings at the 7th meeting of the CoP.

During the CoP, the Commission represented the EU and the EU and its Member States in contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention and other stakeholders, and contributed to the drafting of Conference Room Papers.

After CoP-8, the Commission presented the outcomes of the CoP to DNAs at the 30th DNA meeting on 3 October 2017. The Commission also submitted, together with the Presidency, an information note on the outcomes of the CoP to the Rotterdam, Basel and Stockholm Convention, transmitted by the General Secretariat of the Council to the delegations on 19 June 2017.

CoP-9 (29 April to 10 May 2019)

Before the CoP, the Commission prepared and consulted with the Member States (as it did for previous CoPs) on the position of the EU on matters discussed at the meeting, which consisted of:

·Proposal for a Council Decision establishing the position to be adopted on behalf of the European Union within the Conference of the Parties with regard to amendments of Annex III to the Rotterdam Convention (COM(2019) 54 final) to get the mandate for the participation in the decision-making at the CoP. The proposal was submitted to the Council in February 2019 and adopted on 15 April 2019.

·Comments on amendments proposed by Parties – proposals to amend Articles 16 and 22 of the Convention,

·Comments on the report on legal and operational implications of priority actions to enhance the effectiveness of the Rotterdam Convention, prepared by a working group.

·Commission proposal for a Council Decision on the position to be taken on behalf of the European Union at the Conference of the Parties to the Rotterdam Convention regarding compliance procedures, regarding the proposal to be discussed at the CoP to adopt an additional procedural annex in order to introduce a non-compliance mechanism as required by Article 17 of the Convention.

As for the previous CoP, the Commission contributed to the drafting of the position papers of the EU and its Member States and to the corresponding statements for their participation in the CoP. The position papers and statements cover all agenda items of the meeting.

During the CoP, the Commission represented the EU and the EU and its Member States in contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention and other stakeholders, and contributed to the drafting of Conference Room Papers. As for the previous CoP, and based on the positive experience with the meetings held at CoP-8 between the European Union and its Member States and some groups of other Parties, the Commission consulted DNAs on the organisation of such meetings during CoP-9.

After CoP-9, the Commission presented the outcomes of the CoP to DNAs at the 34th DNA meeting on 15 October 2019. The Commission also submitted, together with the Presidency, an information note on the outcomes of the CoP to the Rotterdam, Basel and Stockholm Conventions, transmitted by the General Secretariat of the Council to the delegations on 26 June 2019.

2.3.2Participation in committees and expert groups

Chemical review committee (CRC)

During the reporting period, five or six EU Member States had nominated experts to participate in the 13th, 14th and 15th meetings of the CRC (including the expert from the United Kingdom, which was a member of the EU during the reporting period) ( Table 6 ). In the 13th meeting of the CRC, in October 2017, two EU representatives acted as Chair and Vice-chair: Mr Jürgen Helbig from the Commission, nominated by Spain (Chair) and Ms Magdalena Frydrych, nominated by Poland (Vice-chair).

Table 6: EU Members of the CRC during the reporting period

Intersessional work on enhancing the effectiveness of the Rotterdam Convention

Following the intersessional work on the process of listing chemicals in Annex III to the Convention and to develop options for improving the effectiveness of the listing process and information flows, which was carried out by a working group between the 7th and the 8th meeting of the CoP, the CoP reviewed, during the 8th meeting, options to improve the effectiveness of the Rotterdam Convention, agreed on further work to be done in the intersessional period and established a working group to identify priority actions to improve the effectiveness of the Convention.

Twelve EU experts (11 from Member States and one from the Commission) were nominated to this intersessional working group:

·One expert from the Federal Ministry for Sustainability and Tourism (Austria);

·One expert from the Federal Public Service Health, Food Chain Safety and Environment (Belgium);

·One expert from the European Commission;

·Two experts from the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (Germany);

·One expert from the Ministry of Environmental Protection and Regional Development (Latvia);

·Two experts from the Ministry of Infrastructure and Environment (Netherlands);

·One expert from the Bureau for Chemical Substances (Poland);

·One expert from the Swedish Chemicals Agency (Sweden);

·Two experts from the Department for Environment, Food and Rural Affairs (Defra), United Kingdom.

After the 8th CoP, the Secretariat of the Convention developed an online survey to be filled by Parties by 31 October 2017 to gather information on priority actions to enhance the effectiveness of the Convention. The Commission, as the EU DNA, coordinated the EU submission – preparing the draft, inviting DNAs to comment, and submitting the final response to the Secretariat.

Following the survey, the working group made a compilation of submissions and drafted a report on the legal and operational implications of priority actions proposed to enhance the effectiveness of the Rotterdam Convention. The Commission coordinated the submission of EU comments on some of these suggestions. Financial support for the intersessional work was also provided by the Commission.

2.3.3Financial contributions to the Rotterdam Convention

As a Party to the Rotterdam Convention, the EU paid the mandatory contribution to the Convention’s Trust Fund and also contributed to the Special Voluntary Trust Fund for the implementation of the programme of work for technical assistance ( Table 7 ).

Table 7:    Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special Voluntary Trust Fund (in EUR, converted from USD to EUR with the exchange rate of the time of payment/commitment)

As all Member States are Parties to the Convention, they also contribute to the Convention’s Trust Fund through their mandatory contributions to the budget of the Convention adopted by the CoP. In addition, some Member States contributed to the Special Voluntary Trust Fund ( Table 8 ).

Table 8: Member States’ contributions to the Special Voluntary Trust Fund (EUR)  13

3Updates of Annex I and Annex V to the PIC Regulation 

Annexes to the PIC Regulation are amended through delegated acts, adopted by the Commission, in accordance with Articles 23 and 26 of the PIC Regulation. The procedure for adoption of delegated acts requires the Commission to consult experts on draft amendments. This consultation is carried out by presenting the drafts at the DNA meetings in order to ensure that all Member State experts, as well as observers, have the opportunity to comment. Delegated acts are also scrutinised by the European Parliament and the Council to ensure that the Commission does not exceed its powers.

3.1Update of Annex I 

Amendments to Parts 1 and 2 of Annex I are triggered by regulatory actions changing the legal status of a substance under other relevant EU legislation, in particular:

·Decision not to approve or to withdraw an active substance under the PPPR;

·Decision not to approve or to withdraw an active substance under the BPR;

·Decision to subject a chemical to authorisation by adding it to the Authorisation List (Annex XIV) of the REACH Regulation;

·Decision to restrict the use of a chemical (Annex XVII) under the REACH Regulation.

Amendments to Part 3 of Annex I reflect the decisions of the CoP to include certain chemicals in Annex III to the Convention, making them subject to the PIC procedure.

During the reporting period, three Delegated Regulations amending Annex I were adopted, in 2017, 2018 and 2019:

·Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending Annexes I and V to Regulation (EU) No 649/2012 (OJ L 32, 6.2.2018, p. 6–11).

·Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending Annexes I and V to Regulation (EU) No 649/2012 (OJ L 59, 27.2.2019, p. 1–7).

·Commission Delegated Regulation (EU) 2019/1701 of 23 July 2019 amending Annexes I and V to Regulation (EU) No 649/2012 (OJ L 260, 11.10.2019, p. 1–7).

Substances added to Annex 1

Of the 37 substances added to Annex I during the reporting period, 23 were proposed for inclusion in Parts 1 and 2 of Annex I to the PIC Regulation because they had been banned for use as plant protection products under Regulation (EC) No 1107/2009, which represented a ban or severe restriction in the use category ‘pesticide’, as shown in Table 9 . Three substances were added to Parts 1 and 2 of Annex I following their non-approval for use in biocidal products in accordance with the BPR (Regulation (EU) No 528/2012). Five were added to Parts 1 and 2 of Annex I because they were severely restricted as industrial chemicals for public use under the REACH Regulation. Finally, six were included in Part 3 of Annex I following their inclusion in Annex III to the Rotterdam Convention.

Table 9: Substances added to Annex 1 during the reporting period

Substances included in Part 3 of Annex I during the reporting period, with the exception of short-chain chlorinated paraffins, had already been included in Parts 1 and 2 of Annex I to the PIC Regulation. Following their inclusion in Annex III to the Convention, corresponding entries in Part 2 of Annex I were deleted and entries in Part 1 of Annex I were amended accordingly.

The substance methamidophos (CAS no 10265-92-6) was included in Annex III to the Convention. As a result, the existing entry in Annex III to the Convention concerning that substance ‘methamidophos (soluble liquid formulations of the substance that exceed 600 g active ingredient/l)’ was deleted and replaced by a new entry for ‘methamidophos’. Commission Delegated Regulation (EU) 2018/172 deleted the existing entry in Part 2 of Annex I, and replaced the existing entries in Parts 1 and 3 of Annex I by a new one, reflecting the changes made to Annex III to the Convention.

Entries of Annex I modified during the reporting period

Tributyltin compounds were already included in Annex III to Convention in the use category ‘pesticide’ since 2008. In 2017, the CoP included tributyltin compounds in Annex III in the use category ‘industrial’. As a result, tributyltin compounds became subject to the prior informed consent procedure under the Convention in the use category ‘industrial’ as well as ‘pesticide’. In addition, tributyltin compounds were added in 2017 14 to substances covered by Entry 30 of Annex XVII to REACH (restriction on substances which are classified as reproductive toxicant category 1A or 1B listed in appendices to the Annex). Commission Delegated Regulation (EU) 2019/330 replaced existing entries in Parts 1 and 3 of Annex I to the PIC Regulation by new entries, reflecting changes made under the Convention and the REACH Regulation.

Entries concerning dichlorvos in Parts 1 and 2 of Annex 1 to the PIC Regulation were amended by Commission Delegated Regulation (EU) 2019/1701 to reflect Commission Decision 2012/254/EU not to include dichlorvos in Annex I, IA or IB to Directive 98/8/EC, which results in dichlorvos being banned from pesticide use.

Substances removed from Annex I

By Implementing Regulations (EU) No 582/2012 and (EU) No 359/2012, bifenthrin and metam were approved, respectively, under the PPPR, with the effect that those substances were no longer banned from pesticide use. As a result, the entries concerning bifenthrin and metam were deleted from Part 1 of Annex I.

3.2Updates of Annex V 

Amendments to Part 1 of Annex V to the PIC Regulation (chemicals subject to export ban) are triggered by the inclusion of a substance in Annex I to the POPs Regulation (Regulation (EU) 2019/1021 15 ). During the reporting period, the following substances were added to Part 1 of Annex V ( Table 10 ).

Table 10: Substances added to Part 1 of Annex V during the reporting period

Part 2 of Annex V to the PIC Regulation lists chemicals subject to export ban other than POPs. To reflect changes brought by Regulation (EU) 2017/852, which modifies the rules on the export of mixtures of metallic mercury with other substances with a mercury concentration of less than 95 %, and of certain mercury compounds, entries in Part 2 of Annex V concerning such mercury compounds and mixtures were amended by Commission Delegated Regulation (EU) 2019/330.

4Operation of the PIC Regulation 

4.1Support to exporters and importers

The Agency is required to provide assistance, as well as technical and scientific guidance and tools, to exporters and importers (Article 6(1)). Although it is not a legal obligation under the PIC Regulation, most DNAs have provided support and carried out awareness-raising activities for national exporters and importers during the reporting period.

Both the Agency and Member States were asked to provide information (in their respective reporting questionnaires) on the awareness-raising and communication activities carried out during the reporting period and requests received from exporters and importers (Section 3 of Member State and the Agency’s questionnaires).

Both DNAs and the Agency stated that the support provided to companies, as well as the awareness-raising activities carried out during the reporting period, had improved exporter and importer compliance with the PIC Regulation.

4.1.1Support provided by DNAs 

Awareness-raising activities

Twenty-seven Member States stated that they had carried out awareness-raising and information activities for exporters and importers during the reporting period ( Figure 2 ). The Member State that did not carry out any such activities is a small Member State, which explained that this was due a limited number of PIC notifications in the country.

As in the previous reporting period, the most common activities carried out by Member States were the provision of online information, such as a specific webpage providing information on the PIC Regulation (22 Member States), and references to the Agency’s webpages on PIC and ePIC (22 Member States). Eleven Member States also provided helpdesk services via an existing helpdesk (e.g. REACH, CLP, BPR) and six operate a national helpdesk; ten Member States indicated having a specific email address for information requirements

As in the previous reporting exercise, almost all of the Member States that carried out awareness-raising considered they have improved exporters’ and importers’ compliance with the PIC Regulation. For example, some DNAs noted an increase in the number of export notifications received by the DNA during the reporting period, improvements in the quality of export notifications, an increase in the number of companies registered in ePIC or using ePIC, or improved compliance with the Article 10 reporting obligations, including compliance with reporting deadlines.

Figure 2:    Question 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?

Requests from exporters and importers

As in the previous reporting period, the most frequent requests from exporters and importers to DNAs relate to export notifications and explicit consents ( Figure 3 ).

Figure 3:    Question 13. On which matters do(es) the DNA(s) get the two most frequent requests for support coming from exporters and importers?

Estimated amount of time spent on support

In the majority of Member States, support to exporters and importers takes up to10% or 20% of the DNA’s workload ( Figure 4 ). Compared to the previous reporting, significantly less Member States selected the option ‘up to 10% of the workload’, and more selected ‘20% of workload’, which may indicate that the time spent on support to exporters and importer has slightly increased since the previous reporting in some Member States. One Member State also selected ‘more than 40% of workload’, which had not been selected in the period 2014-2016. However, there has also been some decrease in workload, as the three Member States that selected ‘40% of workload’ in the previous reporting (Poland, Romania and Spain) indicated this time that support took 30% of their workload. More Member States selected ‘not quantifiable’ than in the previous reporting.

Figure 4: Question 14: Can you estimate the amount of time spent by the DNA(s) on such support?

4.1.2Support provided by the Agency 

Awareness-raising activities

The Agency has fulfilled its obligations under Article 6 of the PIC Regulation through the following activities:

Webpages on the PIC Regulation and ePIC

The Agency has published and translated webpages on the PIC Regulation and ePIC on the

Agency’s website:

· General introduction to the PIC Regulation

· ePIC  

The direct links to all linguistic versions of the PIC Regulation legal texts (initial text, latest consolidated version, and non-consolidated latest amendments) are also made available and kept up-to-date under the section ‘ Legislation ’ of the Agency’s website.

The Agency also publishes on its website the ‘PIC Circular’ issued twice a year by the Secretariat of the Rotterdam Convention.

Internal messaging in ePIC

The communication via messages sent in ePIC is typically used in the following cases:

·To remind exporters/importers of upcoming legal deadlines (e.g. Article 10 reporting deadline);

·To alert or remind exporters of typical shortcomings or elements they should pay attention to in their export notifications;

·To advertise the publication of updated user manuals, new factsheets, etc.;

·To inform of policy changes (e.g. following an agreement at a PIC DNA meeting);

·To alert users in advance of maintenance breaks of ePIC.

Awareness-raising campaign

The Agency reminds exporters and importers of PIC-related issues, such as upcoming legal deadlines, new or clarified legal obligations (such as entry into application of a new amendment to Annex I and/or Annex V, new substances included in existing group entries), or expected workload peaks, using different communication means, including the ECHA Weekly News (by email) or the ECHA Newsletter. These channels were also used to make the promotion of ad hoc activities such as the campaign for improving the quality of the information provided in Section 2 (Prohibited and Allowed uses) of export notifications.

Social media

Since January 2018, ECHA has started to be more active on social media (LinkedIn, Twitter, Facebook) and published various posts relating to the implementation of the PIC Regulation, either for general awareness-raising purposes or on specific topics, such as the publication of ECHA’s Article 10 reports, BREXIT, the ECHA Forum enforcement project on PIC, ECHA’s participation in the meetings of the Parties to the Rotterdam Convention, or the publication of specific guidelines on how to provide information on prohibited and allowed uses in PIC export notifications.

Support to individual companies

This support was mainly provided by the Agency by means of replies to incoming Helpdesk incidents. When needed (e.g. communication/language issues), the Agency also provided ad hoc support over the phone, usually as a follow-up to initial exchanges via the Helpdesk.

Workshops, webinars and similar training events

During the reporting period, ECHA has not organised any specific in-house workshops, webinars or training events. However, the Agency has participated in several conferences during which the PIC Regulation and/or ePIC tool were presented and discussed with the participants from industry mainly.

IT user manuals, factsheets and Q&A (FAQs)

ECHA has regularly updated the ‘ePIC User manual for Industry’ 16 , in order to reflect the successive improvements and new features brought to the ePIC tool. ECHA is also publishing and regularly updating specific ePIC User Manuals for DNAs, for NEAs, for the Commission, and an ePIC User Guide for Customs 17 .

ECHA published during the reporting period four different guidelines (“In brief”

documents) to assist exporting and importing companies on the following key aspects for the fulfilment of their obligations under the PIC Regulation:

· Special RIN requests (August 2017),

· Proposing waivers though ePIC (November 2017),

· Reporting on exports and imports of PIC chemicals (December 2017),

· How to provide information on prohibited and allowed uses in PIC export notifications (October 2018).

In addition, in 2018, ECHA conducted a major review of the existing legal texts developed by the Agency in three Rotterdam Convention languages (EN, ES, FR), with a focus on the texts for the 70 most exported PIC chemicals. ECHA provided these in ePIC for the exporters to use in Section 6.1 (Summary of and reasons for the final regulatory action and date of entry into force) of their export notifications.

Finally, in March 2019, ECHA established a temporary manual procedure for notifying PIC exports to the UK after UK’s withdrawal. ECHA published a guideline on “ How to notify PIC exports to the UK after the UK’s withdrawal from the EU ”, as well as some related PIC-specific information and Q&As, and a manual export notification form, until such export notifications can be made in the ePIC tool.

The effectiveness of the communication activities can be seen in the increasing number of companies registered in ePIC: 1177 registered companies at the end of the previous reporting period (2014-2016) versus 2343 registered companies at the end of this reporting period, of which 578 actively used ePIC in 2019. According to the Agency, the increased visibility given to PIC by ECHA (via information on ECHA’s website, news items, ECHA’s participation in conferences, social media, etc.) has contributed to increasing awareness and compliance with the PIC Regulation.

Requests from exporters and importers

The number of requests received during the reporting period by the Agency helpdesk from exporters and importers remained relatively stable compared to year 2015 and 2016 (2014 was not a full year). However, a notable increase can be observed in 2019, which may be linked to the entry into force of amendments to Annex I ( Table 11 ).

Table 11: Number of requests received by ECHA from exporters and importers since 2014

The largest number of requests from exporters and importers’ concerned:

·Misunderstandings regarding the export notification and related procedures: e.g. exporters’ obligations under PIC depending on which part of Annex I their chemical is listed in, legal deadlines for processing the notification, misunderstanding of when export notifications are needed or not needed, and about the information required to be provided in certain sections of the notification.

·Definitions/ concepts of ‘exporter’ and transit under PIC: which country should be notified when the exporter is located one Member State and the shipment leaves from another, how to deal with situations where when the manufacturer is based in a non-EU country but the chemicals are shipped from the EU.

·Substance identification: whether a substance is subject to PIC or not.

·Article 10 on the reporting required of exporters and importers during the first quarter of each calendar year.

In addition, the Agency received a low number of more complex questions, e.g. the link between the PIC Regulation and other legislation (banning of exports of metallic mercury), the triggering of labelling obligations for mixtures under CLP, or the consequences of the withdrawal of the United Kingdom from the EU for PIC exports to the UK (e.g. when and how to notify the exports/imports to the UK). These questions often require seeking support outside the helpdesk, from expert colleagues in the Agency or the Commission.

The questions related to the ePIC tool and its functionalities have always remained low in number (less than 10 per year) and not representative of any major issue. With the exception of Brexit, which is new, issues on which exporters and importers have asked for support are generally the same as in the previous reporting period.

Estimated amount of time spent on such support

During this reporting period, there has been in average six members (FTEs) of the PIC Operations Team in the Submission and Processing Unit (A3) who are directly involved in providing replies to the requests received from companies via the ECHA Helpdesk. This represents an increase of two FTEs compared to the previous reporting period, where four FTEs were part of Unit A3. As in the previous reporting period, they spent on average, approximately 10 % of their time on this specific activity (for this reporting period 0.6 FTE).

4.2Export notifications sent to Parties and other countries (Article 8)

The export notification is the instrument under the PIC Regulation by which countries exchange information on banned or severely restricted chemicals. All EU based exporters must submit an export notification to their DNA if they intend to export chemicals listed in Part 1 of Annex I to the PIC Regulation to a third country (Party or non-Party to the Rotterdam Convention), irrespective of the use of the chemical in the country of destination. Once the DNA has checked and accepted the notification (after resubmission if necessary), it is forwarded to the Agency, which also verifies the compliance of the notification and transmits it to the DNA of the importing country. If no acknowledgement of receipt is received, the Agency re-sends the notification. The whole procedure is carried out by means of ePIC, and exporters must use the notification template provided by the system.

DNAs and the Agency were asked to provide data on the number of export notifications and Special RIN requests processed during the reporting period, information on difficulties encountered by exporters and authorities in carrying out the procedures, emergency situations, and the provision of additional information on exported chemicals.

The number of export notifications and Special RIN requests increased between 2017 and 2019, and their number varied significantly between Member States. According to the Agency, this shows that compliance has increased during the reporting period. In a relatively high number of cases, the DNAs or the Agency requested resubmission of a notification, usually relating to issues with the filling of section 6.2 of the notification form (Prohibited and Allowed uses). Although some DNAs and the Agency reported problems in complying with the timeframes of the notification procedure, the number of notifications processed late remained low.

4.2.1Export notifications processed during the reporting period 18  

During the reporting period, DNAs accepted and forwarded to the Agency 28 489 export notifications, compared to 15 771 notifications in the previous reporting period, which represent an increase of 81%. The number of notifications accepted and forwarded by DNAs has continuously increased since 2014, although the increase per year is less steep than in the previous reporting period ( Figure 5 ).

Figure 5:    Total number of export notifications accepted and forwarded to the Agency by DNAs per year since 2014 19

The number of export notifications processed varies significantly between Member States ( Figure 6 ). Four Member States did not process any export notification during the reporting period (Cyprus, Greece, Luxembourg and Malta) and two Member States processed fewer than 10 notifications. The highest numbers of export notifications during the reporting period were, as in the previous reporting period, in Germany (8 645 notifications) and France (6 855), followed by Italy (2 453), Spain (2 383) and the UK (2 207).

Figure 6:    Total number of export notifications accepted and forwarded to the Agency by DNAs during the reporting period 

Twenty Member States processed more export notifications during this reporting period compared to the previous one. In nine Member States, the number of notifications processed more than doubled between the two reporting periods. Five Member States saw a decrease in the number of notifications processed and in two Member States, the number of notifications processed remained the same ( Table 12 ).

Table 12:    Total number of export notifications accepted and forwarded to the Agency by DNAs in the reporting periods 2014-2016 and 2017-2019

The Agency also reported an increase in the number of export notifications accepted and processed during the reporting period, from 8 455 in 2017, to 9 704 in 2018, to 10 009 in 2019 20 ( Table 13 ). As mentioned in section 4.1.2, this increase is correlated to the increase in the number of companies involved in PIC activities (1177 companies registered in ePIC at the end of the previous reporting period (2014-2016); 2343 registered companies at the end of this reporting period, of which 578 actively used ePIC in 2019).

Table 13: Export notifications and related tasks handled by the Agency during the reporting period

An acknowledgement of receipt is requested by the Agency for all export notifications sent (not just the first one after Annex I inclusion, as stated in Article 8(3)), as this is an important means of ensuring that the information has been received, especially as contact details in non-EU countries change frequently. These reminders are managed by ePIC automatically so that there is no impact on ECHA’s workload.

4.2.2Special RIN requests processed during the reporting period 

Exporters of chemicals exported for research or analysis purposes in quantities that do not exceed 10kg from each exporter to each importing country per calendar year use the Special RIN request procedure, in which the exporter requests a Special RIN from the DNA. If the request is accepted, this activates a Special RIN that the exporter can use on the customs declaration. The Special RIN request procedure is also used in cases where the exporter is exempt from export notifications, such as emergency situations, when a positive import response has been given by the importing party and when a country has waived its right to be notified.

During the reporting period, DNAs accepted and forwarded to the Agency 11 327 Special RIN requests, compared to 7 072 requests in the previous reporting period, which represent an increase of 60%. The number of Special RIN requests accepted and forwarded by DNAs has continuously increased since 2014 ( Figure 7 ).

Figure 7: Total number of Special RIN requests accepted by DNAs per year since 2014

The number of Special RIN requests processed varies significantly between Member States. As in the previous reporting period, eleven Member States did not have to deal with any Special RIN requests in 2017-2019 (Bulgaria, Cyprus, Estonia, Greece, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, and Slovakia). Germany, Belgium and France were the Member States that accepted the highest number of Special RIN requests ( Figure 8 ).

Figure 8: Total number of Special RIN requests accepted by DNAs during the reporting period

Thirteen Member States processed more Special RIN requests during this reporting period compared to the previous one, although the extent of the increase varies greatly across Member States (from an increase of 8% in the UK to an increase of 264% in Austria). Six Member States saw a decrease in the number of requests processed ( Table 14 ).

Table 14:    Total number of Special RIN requests accepted and forwarded to the Agency by DNAs in the reporting periods 2014-2016 and 2017-2019

4.2.3Requests for resubmission and rejection of export notifications 

Member States requested the resubmission of 5 889 export notifications during the reporting period, compared to 2904 requests for resubmission during the previous reporting period ( Figure 9 ). The increase between the two reporting periods is likely the consequence of the increase in the number of export notifications accepted by DNAs (see section 4.2.1).

Figure 9: Total number of resubmissions of export notifications requested by DNAs per year since 2014

As in the previous reporting period, variations between Member States in the number of resubmissions requested correspond to variations in the number of notifications handled, i.e. Member States that handle a high number of notifications are also generally those that request resubmissions more frequently ( Figure 10 ). 

Figure 10:    Total number of resubmissions of export notifications requested by DNAs in the reporting period

As in the previous reporting period, the main reasons for requesting the resubmission of a notification were that information requirements were not met or issues with the SDS attached to export notification. More specifically, Member States reported the following reasons for requesting resubmission:

·Incorrect filling of section 6.2 (10 Member States): errors in allowed uses, inadequacy of the information provided on prohibited uses and lack of clarity on the use of the exported chemical; issues with section 6.2 ‘The final regulatory action has been taken for the category’ (one Member State mentioned confusion with 3.3 ‘Foreseen category and foreseen use in importing country’);

·SDS not provided in the right language (7 Member States);

·Missing contact information (7 Member States), in particular provision of PO box instead of physical address;

·Absence or issues with SDSs (6 Member States), issues were related to SDSs not corresponding to the notified substance or mixture, or notification and SDSs not consistent with regard to substance percentages in mixtures, or SDSs were attached as "Other document";

·Incorrect filling of section 6.1 (2 Member States);

·Identification of the substance (2 Member States): incorrect name of mixture, wrong concentrations;

·Wrong notification under emergency situation (1 Member State): wrong reason for notifying (emergency situation) to avoid the 35-day period;

·Invalid notifications (1 Member State): different notifications for equally classified substances/mixture, duplicated notifications;

·Expected export date has to be extended (1 Member State).

The Agency requested the resubmission of 2 758 export notifications during the reporting period, compared to 609 during the period 2014-2016 ( Figure 11 ). As above, the increase corresponds to an increase in the number of export notifications handled by the Agency. The trend is similar to that of resubmission requested by DNAs – with a peak in 2018 and decreases in the last year of the reporting period, 2016 and 2019.

Figure 11: Number of resubmissions requested by the Agency per year since 2014 21 .

In 2017, most of the resubmissions were requested following the adoption by ECHA of a stricter approach in checking the content of export notifications, with the aim to ensure that the information in the notifications and the attached SDSs are provided at an appropriate level of quality and language to the authorities of the importing countries. In 2018 and 2019, most of the resubmissions were requested because of unclear or irrelevant information under section 6.2 (Prohibited and Allowed uses), which is also the main reason mentioned by DNAs. Many notifications for which resubmission was requested in 2018 also had incorrect or insufficient contact details for the non-EU importers under Section 3.4, or not matching with the destination country (reason which was also mentioned by seven DNAs). In 2019, many notifications were sent back because of inconsistencies between the concentration of the PIC substance in the mixture as stated in the export notification (Section 2.5) and in the attached Safety Data Sheet.

Member States rejected 544 export notifications during the reporting period, which is significantly less than in the previous reporting period, where 1,214 notifications were rejected by DNAs. Following a peak of notifications rejected in 2016, the number of notifications rejected has continuously decreased during the reporting period ( Figure 12 ).

Figure 12: Total number of export notifications rejected by DNAs per year since 2014

As above, variations between Member States in the number of notifications rejected correspond to variations in the number of notifications handled, i.e. Member States that handle a high number of notifications are also generally those that reject notifications more frequently ( Figure 13 ). 

Figure 13: Total number of export notifications rejected by DNAs during the reporting period

As in the previous reporting period, the main reason reported by DNAs to reject a notification is the duplication of notifications, which was mentioned by ten Member States. Other reasons mentioned were that the notification was not applicable because the right to receive the notification was waived by the importing country, or the resubmission was late (one Member State) or the company contacted the DNA and informed that the export notification was submitted incorrectly.

Unlike DNAs, the Agency rejected more notifications (212) during the reporting period than in the period 2014-2016 (175 notifications), mostly because of a peak in the last year of the reporting period, 2019. Such a peak in the last year of the reporting could already be observed in the previous reporting period, in 2016 ( Figure 14 ).

Figure 14: Number of export notifications rejected by the Agency per year since 2014

In 2017, most of the rejections were made at exporters’ request (e.g. exports cancelled; one already validated notification could cover similar mixtures for which other export notifications are not needed). The main reason for rejecting the export notifications in 2018 was that the importing country has waived the right to receive export notifications for certain chemicals from the EU (Brazil); another representative reason for rejection was that the concentration of the PIC substance in the export notification did not trigger labelling obligations under CLP. In 2019, most of the rejections were due to unnecessary duplicate notifications; there were other various reasons such as the selection of the wrong template for the notification (e.g. mixture instead of pure substance) or a mismatch between the stated importing country and the importer’s address.

4.2.4Difficulties encountered in the export notification procedure 

Difficulties encountered by exporters in completing the export notification form

According to the DNAs, exporters have mainly experienced difficulties to provide information on the intended use of the chemical in the importing country, and to a lesser extent on the availability of CN codes or CUS codes, and on the export itself, such as the contact details of the importer. The top three information requirements are the same as in the previous reporting period. Compared to the previous reporting, the number of Member States replying ‘none’ has significantly increased ( Figure 15 ).

Figure 15:    Question 19. What are the information requirements requested in the export notification form where exporters have difficulties in providing the information?

In addition to these issues, DNAs highlighted issues with the language of SDSs and with intended uses reported by Member States.

When processing export notifications, ECHA has noticed the following issues/ mistakes:

·Duplication of notifications.

·If their chemical is not in ePIC, companies are not sure whether or not its export is subject to the PIC Regulation (this issue relates specifically to group entries, e.g. cadmium and its compounds, for which the list of cadmium compounds in ePIC is not comprehensive).

·Some exporters confuse export notifications for substances and for mixtures and use the wrong template.

·Section 3.3 of the export notification (foreseen category and use in importing country) is often confused with section 6.2 (category for which the FRA was taken).

·The intended use and use category for exports of biocides can be problematic due to the fact that the EU considers ‘biocides’ to be a sub-category of the pesticides category, whereas many non-EU countries consider biocides industrial chemicals.

·The foreseen uses in the importing country under Section 3.3 are often inadequately described, in particular due to the fact that the field is provided as free text only, and therefore without any structured sub-categorization of uses.

·The prohibited uses and allowed uses described under Section 6.2 are often incorrect or misleading, and reflecting more the intended uses in the importing country than the regulatory status of uses within the EU.

·The “Produced / Imported / Exported / Used” fields under Section 6.2 are usually left empty, but often filled in with incorrect data too, sometimes referring to quantities that are specific to the exporter instead of quantities that are to be reported at EU level.

·Not all companies provide the SDS (or equivalent information) in the official language of the importing country or in an appropriate language. ECHA has however noticed some improvement with regard to this issue, and in particular since new features were added in ePIC to raise the attention of the exporters.

According to the Agency and the DNAs, section 6.2 is one of the sections of the notification for which exporters experience most difficulties in providing the requested information. It is also one of the main reasons for resubmission requests. Therefore the Agency suggests to explore the possible ways and means to improve the overall efficiency and usefulness of the information provided under this sub-Section, namely through improved data structure. Since these information requirements in ePIC are derived from Article 8, paragraph 2 and Annex II to the PIC Regulation, necessary changes to the PIC Regulation legal text may however be needed. Depending on the changes considered, adaptations to ePIC and to the export notification template as sent to importing countries, may be required too.

Section 3.3 is another section of the export notification that is also often incorrectly filled by exporters according to the Agency and DNAs. To address the issue, the Agency suggests integrating a more detailed and structured sub-categorization of foreseen uses could be introduced in the formats for export notifications in ePIC. Adaptations to ePIC and to the export notification template as sent to importing countries, would however be required.

Complying with timeframes

According to the Agency, DNAs experienced difficulties in coping with the timeframe to forward the export notifications to ECHA, as shown by the increasing number of late notifications. As shown in Table 15 , the number of export notifications forwarded late remains relatively low compared to the total number of notifications processed (6.3% of the total number of notifications).

Table 15: Number of export notifications received late by the Agency since 2014

ECHA has noticed that the difficulties of certain Member States to cope with the legal timeframe for the checking export notifications usually appears during and right after peak submission periods, i.e. in November/December/January months, and especially when those coincide with holiday periods when very limited or no resources are available.

Three Member States (compared to seven in the previous reporting period) reported difficulties in complying with a timeframe to forward the notifications to the Agency. Those three Member States are among the Member States that process the largest number of export notifications (France, Germany and Italy). Two of them explained that companies often do not respect deadlines for resubmission, making it difficult for the DNA to forward the notification to ECHA according to the set timeframe. All three Member States mentioned the difficulties to manage the notifications in compliance with the timeframe during the ‘peak season’ (October to January/February).

As in the previous reporting period, the Agency indicated that it experienced difficulties in coping with the timeframe to process and forward export notifications to the importing country. The number of late notifications remains very low (0.2%) even though it increased since the previous reporting period (see Table 16 ). According to the Agency, the delay, in many cases, because the tasks had been already processed late by the DNA and therefore ECHA received the task very close to the due date. For a number of cases, it was the Agency (and not the Member State DNA) who missed its legal deadline for processing, typically due to IT-related issues or a need for policy consultation. In case of delays, the authority in the importing country has always been informed accordingly.

Table 16: Number of export notifications processed late by the Agency since 2014

4.2.5Emergency situations (Article 8(5))

According to Article 8(5), when the export relates to an emergency situation in which any delay may endanger public health or the environment in the importing country, the DNA, in consultation with the Commission, may exempt the exporter from the notification requirements or the waiting period. During the reporting period, received 15 export notifications flagged as referring to the export of a chemical related to an emergency situation. According to the Agency, most of them (13) did not meet the criteria described in Article 8(5) and, when available, were providing justifications relating to economic considerations rather than to the protection of public health or the environment. In those cases, the Agency rejected the notification and invited the company to submit a new ‘standard’ export notification. The Agency however notes that the exporter’s DNA should have rejected the notification instead of forwarding it to ECHA. Only two export notifications were validated as per Article 8(5) during the reporting period.

Only one Member State (United Kingdom) had to deal with an emergency situation during the reporting period (in 2019). The emergency situation was related to Ethylene oxide for sterilization purposes (in the health system) in Cuba and the Member State had no difficulties implementing the procedure.

4.2.6Provision of available additional information on exported chemicals

According to Article 8(7), the Commission, DNAs, the Agency and exporters should provide additional information on the exported chemicals, at the request of the importing party. As in the previous reporting period, the Agency received a relatively high number of requests from authorities in non-EU importing countries to provide additional information or clarifications on exported chemicals. As in the previous reporting period, these requests typically related to additional information on the importing company, clarification on the intended use of the chemical in the importing country or on the quantities exported, clarification on the reasons for notifying the export of the chemical or for requesting the explicit consent for chemicals which are not listed in Annex III to the Rotterdam Convention, and cases where the export notification was sent to the wrong authority.

Five DNAs (compared to eight in the previous reporting period) received similar requests. Information requested by the importing countries related primarily to importer contact details. One DNA also mentioned having provided general information related to labelling and other similar issues, including through Customs Officials.

4.2.7Administrative fee for export notifications

Member States are allowed to establish administrative fees for exporters for each export notification and for each request for explicit consent made, corresponding to the cost they incur in carrying out the procedures. As in the previous reporting period, eight Member States have requested an administrative fee for export notifications (Belgium, Bulgaria, Finland, Germany, Greece, Hungary, Portugal, and Slovenia), and these fees vary greatly between Member States (from EUR 25 to EUR 265). Fee amounts have not changed since the previous reporting period.

Four Member States have established a fee for requests for explicit consent (Bulgaria, Finland, Germany and Portugal). In the previous reporting period, Bulgaria was not requesting a fee. In Finland, Germany, and Portugal, the amount of the fee has not changed since the previous reporting period, varying from EUR 25 to EUR 265.

As in the previous reporting period, Member States have received no complaints from exporters on the amount of the fees, nor did they note any significant impact of the fees on the number of export notifications.

4.3Export notifications from Parties and other countries (Article 9) 

As per Article 9, the Agency must make available on its database the export notifications it receives from non-EU countries, acknowledge receipt of the notification to the DNA of the exporting country and provide a copy to the DNA of the Member State(s) receiving the import. The Agency was asked to provide information on the export notifications received and acknowledgements sent.

The Agency received 1 371 export notifications from non-EU countries in the reporting period, which is slightly higher than in the previous reporting period (1 105 notifications) (see Table 17 ). The number of notifications almost remained stabled over the reporting period.

Table 17:    Export notifications received from non-EU countries and acknowledgements sent during the reporting period

The difference between the number of notifications received and the number of acknowledgements sent is due to the fact that the Agency does not send acknowledgements of receipt to the United States of America (USA), based on a bilateral agreement, while the USA is the country sending the greatest number of export notifications to the EU, based on their national legislation and notwithstanding that the USA is not a Party to the Convention.

4.4Information on export and import of chemicals (Article 10)

Article 10 places obligations on exporters and importers to inform the DNA of the quantity of chemicals listed in Annex I of the PIC Regulation exported to or imported from third countries during the preceding year. This must be done during the first quarter of each year. Exporters must also provide the DNA with the names and addresses of each importer. DNAs must, in turn, provide this information to the Agency annually, which then aggregates the data at EU level and makes it publicly available on its database.

DNAs and the Agency were asked (in their respective questionnaires) about any delays and difficulties encountered in fulfilling their obligations under Article 10. As in the previous reporting period, their responses suggest that the reporting under Article 10 works well.

Delays in collecting information

Seven Member States (compared to ten in the previous reporting period) stated that they experienced delays from exporters in the submission of information on the quantity of the chemical exported, requiring to send reminders. Five of these seven Member States had already reported delays in the previous reporting period. Five Member States (compared to eight in the previous reporting period) indicated that they had experienced delays from importers in submitting their information. As in the previous reporting period, the Agency did not encounter delays from DNAs in receiving the aggregated national reports on the quantity of exported and imported chemicals, suggesting that delays from exporters and importers did not affect the completion of the reporting exercise under Article 10.

Reporting through ePIC

Only two Member States reported difficulties or delays in doing their article 10 reporting through ePIC, caused by delays, mistakes, or incorrect contact details in exporters / importers’ reporting.

Aggregating information at EU level

According to the Agency, reporting from DNAs has improved compared to the previous reporting period as less DNAs reported data that are out of scope of Article 10 reporting (such as data on exports of PIC chemicals exported for research and analysis purposes below 10kg per year and per importing country). However, some of the data submitted by DNAs contained errors derived from industry reporting and required correction, re-aggregation and resubmission of the reports by the DNAs. According to the Agency, this has led to inefficiencies and delays in the preparation of the overall report as well as to errors not being identified by ECHA and published, as ECHA’s capacity to perform a quality check is very limited. The Agency therefore recommended that DNAs increase verification of aggregated data before submission.

Use of Article 10 data

Data gathered for the purposes of Article 10 reporting are used by the DNAs, customs or other enforcement authorities in 15 Member States (which is roughly similar to the previous reporting period where 16 Member States had replied that they used this data). Five DNAs specifically mentioned the data is used by customs authorities. Seven DNAs indicated that the data are used for enforcement activities, with two specifying that it is used for checking compliance with REACH restrictions.

4.5Notification of banned or severely restricted chemicals under the Convention (Article 11-12)

As per Article 11 of the PIC Regulation, the Commission must notify the Secretariat of the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I, which qualify for PIC notification. The Commission, assisted by the Agency, drafted the notifications and submitted these to the DNAs and other stakeholders for comments before submitting them to the Secretariat. Ten notifications were submitted to the Secretariat during the reporting period:

·Acetochlor (2017) 

·Amitrole (2019)

·Beta-cypermethrin (2019)

·Cybutryne (2019)

·Flupyrsulfuron-methyl (2019)

·Iprodione (2019)

·Isoproturon (2019)

·Orthosulfamuron (2019)

·Picoxystrobin (2019)

·Triasulfuron (2019)

4.6Obligations in relation to importing chemicals (Article 13)

As per Article 10 of the Convention, Parties are requested to adopt an import decision for each new chemical listed in Annex III and to submit it to the Secretariat within nine months of receipt of the notification of the listing and the decision guidance document. Pursuant to Article 13 of the PIC Regulation, the Union import decision is adopted by means of an implementing act of the Commission. The Commission services draft the implementing act containing relevant import decisions, which is then submitted to the REACH Committee for an opinion, in accordance with the advisory procedure.

During the reporting period, the Commission adopted one Implementing Decision in 2018 (see Table 18 ). The Implementing Decision provided new import decisions for carbofuran, trichlorfon, short-chain chlorinated paraffins, tributyltin compounds and amended the import decision on ethylene oxide.

Article 13(5) requires the DNAs to make EU import decisions available to those concerned within their competence. As in the previous reporting exercise, DNAs fulfil this requirement by email and by publishing those decisions on their website.

Table 18: EU import responses adopted during the reporting period

4.7Obligations in relation to exports of chemicals, other than export notifications (Article 14)

Article 14 requires the explicit consent of the importing country before an export of chemicals listed in Parts 2 or 3 of Annex I can proceed, unless a positive import response is available in the latest PIC Circular for chemicals listed in Part 3 of Annex I.

DNAs and the Agency were asked to provide data on explicit consent procedures carried out during the reporting period, as well as any difficulties they encountered in doing so. Nineteen Member States implemented the explicit consent procedure during the last three years, highlighting late or no response from some importing countries as the main challenge. Fewer Member States dealt with Article 14(6) and (7) provisions, and the information provided by DNAs suggests that few implementation problems occurred. Although, according to the Agency, it is still challenging to implement Article 14(8), the number of problematic cases has been substantially reduced.

4.7.1Communication of information and decisions to those concerned within the jurisdiction of a Member State (Article 14(3))

Article 14(1) requires the Commission to forward PIC circulars and other relevant information received from the Secretariat of the Convention to Member States, the Agency, and industry associations. The Member States then communicate this information to those concerned in their jurisdiction. As in the previous reporting period, all DNAs fulfil this requirement, mainly through emails and the provision of information on their website (Article 14(3)).

4.7.2Explicit consent (Article 14(6)) 22

Nineteen Member States (as in the previous reporting period) sought explicit consent from the DNA of the importing country, under Article 14(6)(a) of the PIC Regulation. A total of 5 058 requests for explicit consent were processed by DNAs between 2017 and 2019, which is higher than in the previous reporting period where 3 362 requests were processed by DNAs. As in the previous reporting period, the Member States that have processed the highest number of requests are Germany, France, Belgium, Spain, the United Kingdom and the Netherlands ( Figure 16 ). In 15 Member States (out of 19), the number of requests processed by the DNA was higher than in the previous reporting period. In some cases, the increase is quite significant (e.g. from 283 requests in 2014-2016 to 872 in 2017-2019 in Belgium, from 559 to 1045 in France, from 10 to 54 in Ireland, from 47 to 80 in Poland, or from 4 to 37 in Slovenia).

Figure 16: Number of requests for explicit consent received by DNAs during the reporting period

Of the 5 058 requests for explicit consent, 54% received responses following either the initial request, the first or the second reminder, which is a roughly similar response rate compared to the previous reporting period. In 23 % of cases, the response is received after the first reminder (see Table 19 ). Despite an overall response rate that remains rather low, the system of reminders – of which the vast majority is triggered and sent automatically – is considered as effective and efficient by the Agency.

Table 19: Reminders for explicit consent requests sent by the Agency during the reporting period

During the reporting period, there were 14 instances in Germany and Spain where for chemicals listed in Part 3 of Annex I, explicit consent from the DNA of the importing country was provided by the latest circular issued by the Secretariat of the Rotterdam Convention, according to Article 14(6)(b) (see Table 20 ).

Table 20: Number of requests for explicit consent pursuant to Article 14(6)(b) 23  

Difficulties encountered in the implementation of the explicit consent procedure

Ten Member States reported having experienced difficulties in implementing the explicit consent procedure. As in the previous reporting period, the main challenge reported by DNAs was late responses from importing countries to consent requests (i.e. after the 60-day waiting period) or no response at all. The DNAs also stated that the response provided was not always clear or was difficult to interpret, that certain countries were particularly difficult to reach (e.g. where the request had to be sent by regular mail), and that certain countries imposed additional national rules that caused further delays. To improve the processing of requests for explicit consent, one DNA suggested that it would be useful for processing DNAs to receive an email alert from ePIC indicating when responses to explicit consent requests have not been received after 30 and 60 days so the DNA can advise companies in relation to waivers.

The Agency’s involvement in the explicit consent procedure consists of verifying the metadata associated with explicit consent requests after it is uploaded to ePIC by the DNA (and before it can be used for processing purposes). As in the previous reporting period, the Agency considered that this process is working smoothly and that collaboration with DNAs in cases where the interpretation of the explicit consent is difficult is effective. The process has contributed, according to the Agency, to harmonised data and the reduction of clerical errors during the procedure.

4.7.3Waivers (Article 14(6) and (7))

Explicit consent in case of exports of chemicals listed in Part 2 of Annex I to OECD countries

According to Article 14(6), when a chemical qualifying for PIC notification is exported to an OECD country, the DNA can waive the requirement for explicit consent on a case-by-case basis, at the request of the exporter and after consulting the Commission. Eight Member States (compared to six in the previous reporting period) were requested to decide whether or not explicit consent was required in the case of export of chemicals listed in Part 2 of Annex I to OECD countries (see Table 21 ). The number of cases varies greatly between Member States from four cases in Spain to 30 in Italy. In the previous reporting period, Italy had already the highest number of cases (49 in the period 2014-2016).

Table 21:    Number of cases where DNAs were required to decide whether or not explicit consent was required in case of export of chemicals listed in Part 2 of Annex I to OECD countries 

One Member State reported difficulties in taking this decision, explaining that companies often do not give information on the legislation and/or database belonging to the OECD country, which is important for the exporter's DNA in its verification activity.

DNA decisions that export may proceed 60 days after an explicit consent request was made

According to Article 14(7), the DNA of the exporting country can take the decision, on a case-by-case basis and in consultation with the Commission, assisted by the Agency, to waive the explicit consent requirement when no reply from the importing country has been received after 60 days. Such waivers can only be granted if certain conditions are met and for a maximum period of 12 months, after which time the exporter will need to seek explicit consent again. Thirteen Member States (compared to 11 in the previous reporting period) received waiver requests in accordance with Article 14(7) during the reporting period (see Table 22 ). The number of waiver requests received by DNAs varies greatly between Member States, from one request in Hungary to 148 in Belgium.

Table 22: Number of waiver requests received per Member State during the reporting period

Four Member States stated that they experienced difficulties in implementing the waiver procedure. One of these DNAs reported difficulties with documents submitted in non-EU language for which translations had to be requested. Another DNA reported difficulties to verify whether Article 14.7 is fulfilled based on the information provided.

The Commission generally considered that the waiver procedure worked smoothly during the reporting period, and that collaboration with the DNAs was positive. The Agency has noted a decrease in the recurrence of some issues such as missing translations or incorrect validity dates. However, the Agency sometimes had exchanges with the Commission, leading to the revision of the decision. The Agency has published in 2017 guidelines (“In brief” document) to assist exporting companies in proposing waivers through ePIC, which has, according to the Agency, also led to a reduction in the number of problematic cases and needs for revisions / resubmissions / rejections. One DNA confirmed it explaining that their handling of waivers has improved since the publication of the guidelines.

As mentioned previously, the Agency considers that it would simplify the procedure and improve the overall efficiency of the waivers process, if it played an earlier and/or enhanced role in the waiver approval workflow.

4.7.4Validity of explicit consent (Article 14(8))

According to the procedure described in Article 14(6), explicit consent, once obtained, is valid for three calendar years, after which it must be requested again, unless the terms of the consent require otherwise. Export may continue for an additional 12 months after the three-year period, however, pending a response to a new request for explicit consent.

Fifteen Member States experienced cases where the export was allowed to proceed pending a reply to a new request for explicit consent (see Table 23 ). The highest number was reported by France, with 193 cases in total.

Table 23:    Number of cases where the export was allowed to proceed pending a reply to a new request for explicit consent, by Member State, during the reporting period

According to the Agency, Article 14(8) remained challenging to implement during this reporting period. However, the number of problem cases (i.e. in which the Agency and the DNAs disagree on the interpretation) has been substantially reduced after it was discussed at DNA meeting level in the previous reporting period (April 2015) and the related ePIC functionality was enhanced accordingly.

4.8Information on transit movement (Article 16)

None of the Member States implemented Article 16 during the reporting period (as in the previous reporting period 2014-2016).

4.9Requirements linked to exported chemicals and accompanying information (Article 17)

Article 17 states that exported chemicals must be packaged and labelled in accordance with the provisions on packaging and labelling in the CLP Regulation, the PPPR and the BPR. The information on the label must also include the expiry date (for different climate zones if necessary) and the production date. An SDS compliant with Annex II of the REACH Regulation must be sent to each importer, together with the chemical. The information on the label and the SDS should 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, insofar as possible.

The DNAs were asked to provide information on compliance issues observed during the reporting period. Only few Member States reported compliance issues; these mainly related to packaging requirements under the CLP Regulation and the SDS.

Compliance issues relating to packaging and labelling requirements

The national enforcement authorities in six Member States (compared to eight in the previous reporting exercise) experienced compliance issues concerning the information accompanying exported chemicals. Five of these six Member States indicated that they had identified compliance issues relating to the packaging requirements of the CLP Regulation. None of the six Member States reported compliance issues related to packaging requirements linked to the PPPR or the BPR (while in the previous reporting exercise three Member States reported issues linked to the BPR and two to the PPPR).

Compliance issues with the SDS and the language(s) of the label or SDS

Five Member States reported finding compliance issues relating to the application of SDS requirements under the REACH Regulation.

Other compliance issues concerned the obligation to give information in one or more official/principal languages of the country of destination, on the label (three Member States) and on the SDS (two Member States).

Finally, three Member States reported experiencing compliance issues regarding the information and packaging requirements linked to the exported products. Two indicated that these compliance issues were related to the expiry date, one to the storage conditions on the label, one to export or import bans, and one indicated that these compliance issues were related to language (i.e. the information on the label is not given in the language of the country of destination).

4.10Enforcement of the PIC Regulation (Article 18)

According to Article 18 of the PIC Regulation, Member States must designate authorities (such as customs authorities) to control the import and export of chemicals listed in Annex I. The Commission, supported by the Agency, and the Member States must coordinate their enforcement activities in respect of the PIC Regulation. The Forum for Exchange of Information on Enforcement, established by the REACH Regulation, should also be used to coordinate the network of authorities responsible for enforcement of the PIC Regulation.

Article 18 states that Member States must provide information on the activities of their enforcement authorities in their Article 22 reports. The questionnaire asked Member States to report on: the organisation of enforcement activities at national level and their enforcement strategy; training of inspectors; enforcement actions and their penalty system; collaboration between National Enforcement Authorities (NEA) and DNAs and Forum activities; and asked them to provide data on the enforcement activities and infringements observed during the reporting period.

Information provided by the DNAs shows that all Member States have put in place a system to ensure compliance with the PIC Regulation. All Member States have nominated authorities responsible for the enforcement of the PIC Regulation (in most Member States, this is the customs authority and the environmental/health inspectorate). Seventeen Member States have put in place an enforcement strategy (including rules of procedures, written instructions, etc.), and over half have established regular training of inspectors. Sixteen Member States reported having carried out controls on exports and 12 on imports during the reporting period. As in the previous reporting period, few infringements were detected. Finally, DNA feedback on the Forum activities was positive.

4.10.1National enforcement authorities (NEAs)

Most Member States have several authorities in charge of enforcing the PIC Regulation. As in the previous reporting exercise, customs are involved in the implementation of the PIC Regulation in all Member States except Malta and the United Kingdom. In six countries, the customs administration is the only NEA (Czechia, Italy, Latvia, Poland, Slovakia and Spain). In the previous reporting period, it was the case only in four Member States 24 . Other enforcement authorities are typically environmental, chemical and/or health inspection services. In eleven Member States, the NEA is part of the same institution as the DNA.

In almost all the Member States, authorities involved in the enforcement of the PIC Regulation are also typically involved in the enforcement of the CLP Regulation (25 Member States), the REACH Regulation (25 Member States), and the BPR (21 Member States).

Fifteen Member States (compared to 18 in the previous reporting period) indicated that NEAs have sufficient resources to carry out their obligations under the PIC Regulation, while eight (compared to seven in the previous reporting period) stated they do not have appropriate resources. Among those eight Member States, four had already stated in 2014-2016 that they lacked resources, and three had stated on the contrary that their resources were appropriate in the previous reporting period. Three Member States that had stated in 2014-2016 that they did not have appropriate resources stated in this reporting period that they do. Where Member States pointed to insufficient resources in NEAs, they referred specifically to the lack of human resources (inspectors or customs officers), in particular for doing physical checks.

4.10.2Training inspectors 

Sixteen Member States (compared to 15 in the previous reporting period) indicated that inspectors are regularly trained on the PIC Regulation. Three Member States that had stated in 2014-2016 that inspectors were not regularly trained replied that they have been trained regularly during this reporting period.

Among the Member States that have organised regular training, twelve mentioned training activities addressed to inspectors, and four mentioned training activities addressed to customs’ officers. Six stated that such training is included as part of general training on chemicals legislation. DNAs mentioned various types of activities, including meetings, training from Forum pilot project, etc.

Most Member States that have not organised regular training on the PIC Regulation explained either that training was done on a more ad-hoc basis (meetings, internal exchanges) or that PIC training had been provided initially in the previous reporting period but was not renewed in this reporting period because no specific need arose (e.g. staff has not changed).

4.10.3Enforcement strategy 

Seventeen Member States (compared to 16 in the previous reporting period) reported having a strategy for the enforcement of the PIC Regulation, out of which 16 have already fully implemented that strategy, and one has implemented it partially ( Figure 17 ). Three Member States that did not have a strategy in the previous reporting period have stated that they had one during this reporting period (Denmark, Greece and Malta). Two Member States that had reported having a strategy in the period 2014-2016, indicated not having one during this reporting period (Italy and Lithuania).

Figure 17:    Question 62. Does your authority (or any other relevant authority) have an enforcement strategy for Regulation (EU) No 649/2012?

4.10.4Enforcement activities 

During the reporting period, documentary checks were carried out in around two thirds of the Member States (19), while less than half reported carrying out proactive inspections or on site checks ( Figure 18 ).

Figure 18: Enforcement activities carried out in Member States 25  

Four Member States mentioned other enforcement activities:

·Forum PIC pilot project in 2018;

·Custom checks of customs declaration, RIN or special RIN, consistency of annexed documents, labelling requirements, provision of Safety Data Sheet, where relevant of import decision

·Customs’ physical inspections of goods

Ten Member States (compared to 13 in the previous reporting period), reported that customs authorities performed controls related to the PIC Regulation during the reporting period, representing the largest number of controls in those countries. Eleven Member States reported controls performed by NEAs. Table 24 presents the data reported by DNAs. 

In four Member States, customs carried out controls on imports during the reporting period. NEAs reported performing controls on imports in ten Member States. DNAs reported the data contained in Table 25 .

Table 24:    Total number of official controls on exports in which the PIC Regulation was covered or enforced during the reporting period, by Member State

Table 25:    Total number of official controls on imports in which the PIC Regulation was covered or enforced during the reporting period, by Member State

As part of its report, the Agency provided estimates of the use of the ePIC customs interface by DNAs. As the customs interface is used by customs authorities for control purposes, data provided by DNAs can be checked against the data provided by ECHA (although it should be noted that only 23 Member States consulted the application). Based on the numbers provided by the Agency, on average 5 500 customs controls have been carried out through the ePIC customs interface. More specifically:

·One Member State checked > 2 200 individual notifications.

·One Member State checked ~850 individual notifications.

·Four Member States checked between 200 - 600 individual notifications.

·Four Member States checked between 100 - 200 individual notifications.

·Ten Member States checked between 10 - 50 individual notifications.

·Three Member States checked < 10 individual notifications.

4.10.5Powers of enforcement authorities