Annexes to COM(2023)783 - Amendment of Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)783 - Amendment of Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and ... |
|---|---|
| document | COM(2023)783  |
| date | December 7, 2023 |
Changes to medical devices regulation will not require any additional resources for ECHA. The work is currently performed by the Commission supported by the SCHEER committee. The current resource use is estimated to be 0.3 FTE per year and EUR 24 000 per year. Considering that the envisaged frequency of the work is very low, the involvement of the Committees is only where necessary and the first work will likely materialise only in 2029, the work can be absorbed by ECHA without any additional resources.
Changes to the regulation on the EEA and to the regulation on the general principles and requirements of food law and establishing the European Food Safety Authority will have no resource implications. The provisions formalise the activities already performed, they prescribe the procedural steps to follow and they enable the implementation of the proposal for a regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals. Any possible resource needs stemming from these provisions can be absorbed by the existing resources of the agencies.
| Resource needs for ECHA per legislation amended via the proposal for a Regulation amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/754 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union Agencies in the area of chemicals | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Legislation | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| Proposal for a regulation on reattribution of scientific and technical work | |||||||||
| POPs regulation | 1 | 0 | 2 | 0 | 2 | 0 | 35 | 50 | 50 |
| Medical devices regulation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SUM | 1 | 0 | 2 | 0 | 2 | 0 | 35 | 50 | 50 |
| Current resource use for technical and scientific work to be reattributed to ECHA via the proposal for a Regulation amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/754 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union Agencies in the area of chemicals | |
| POPs regulation ·Technical assistance in reviewing Annexes IV and V ·Hosting POPs monitoring data | Total ca. 1.5 FTEs/year: EUR 300 000 for consultants every 3 years (=1.5 FTE/year); (In addition, DG ENV ca. 0.5 FTE/year (implementing the review of Annexes IV and V) whose work will remain) |
| Medical devices regulation ·Preparation and review of the guidelines on how to perform the benefit-risk assessment of the presence of phthalates in medical devices ·Preparation and review of the guidelines on how to perform the benefit-risk assessment of the presence of CMR and endocrine-disrupting substances in medical devices | Total ca. 0.3 FTE/year + EUR 24 000 per year: DG SANTE SCHEER secretariat 0.3 FTE (ca. 10% of SCHEER secretariat work), EUR 24 000 per year for indemnities, travel, e.g. costs for members of the committee. (In addition, DG SANTE (policy unit) 0.1 FTE/year whose work will remain). |
| SUm | 0.3 FTEs/year of regular staff; 1.5 FTEs/year of intramurous contractors or interim staff (ca. EUR 100 000/year); Operational costs of ca. EUR 24 000/year |
In summary, in the first year, there will be a need of 1 FTE (1 TA) and operational costs of EUR 35 000 per year and as of the second year, there will be a need of 2 FTEs (2 TAs) per year and operational budget of EUR 50 000 per year. All new resources are needed for ECHA. Considering the resources currently used for the tasks to be reattributed, there will be a total net increase in the resources from 2026 and beyond as compared to today of 0.2 FTEs per year and operational costs of EUR 26 000 per year.
| Resource needs for ECHA for proposal for a Directive amending Directive 2011/65/EU as regards the reattribution of scientific and technical tasks to the European Chemicals Agency | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Legislation | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| RoHS directive | 3 | 0 | 4 | 3 | 4 | 3 | 66 | 33 | 33 |
| SUM | 3 | 0 | 4 | 3 | 4 | 3 | 66 | 33 | 33 |
| Current resource use for technical and scientific work to be reattributed to ECHA via the proposal for a Directive amending Directive 2011/65/EU as regards the reattribution of scientific and technical tasks to the European Chemicals Agency | |
| RoHS directive ·Assessments underpinning restrictions of hazardous substances in electrical and electronic equipment ·Review of applications for exemptions from the restrictions | Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for outsourcing the review of exemptions (= ca. 2.2 FTEs/year) + a contract of EUR 180 000 on average each 5 years for reviewing restrictions (= 0.54 FTE/year). (In addition, DG ENV ca. 1.5 FTE/year (for overall RoHS implementation) whose work will remain) |
| SUm | 2.7 FTEs/year of intramurous contractors or interim staff (ca. EUR 181 000 per year); |
In summary, in the first year, there will be a need of 3 FTEs (3 TAs) and operational budget of EUR 66 000 per year and as of the second year, there will be a need of 7 FTEs (4 TAs + 3 CAs) per year and operational budget of EUR 33 000 per year. All new resources are needed for ECHA. Considering the resources currently used for the tasks to be reattributed, there will be a total net increase in the resources from 2026 and beyond as compared to today of 4.3 FTEs per year and EUR 33 000 per year.
The work will require resources for 4 agencies involved and the Commission (JRC). The resource requirement is higher for the first 3 years to set up the infrastructure and all the underlying processes to share the data and make them interoperable and in adequate formats. This will require for the first 3 years:
- for ECHA, 10 FTEs (4 TAs + 6 CAs) per year and operational budget of EUR 0 for the first year, EUR 2 226 000 for the second year and EUR 2 793 000 for the third year;
- for EEA, 3 FTEs (1 TA + 2 CAs) per year and operational budget of EUR 0 for the first year, EUR 266 000 for the second year and EUR 334 000 for the third year;
- for EFSA, 5 FTEs (5 CAs) per year and an operational budget of EUR 670 000 per year. For this purpose, a contribution/service level agreement of EUR 3 000 000 will be signed to cover the 3 FTEs (3 CAs) per year and the operational budget needed. The additional 2 FTEs (2 CAs) per year will be financed from EFSA’s current budget;
- for EMA, a contribution/service level agreement of EUR 1 400 000 to cover 3 FTEs (3 CAs) per year and an operational budget of EUR 100 000 per year;
- for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;
- for JRC, an administrative arrangement for 3 years of EUR 540 000 to cover integration of IPCHEM in the common data platform and handing over of IPCHEM operation to ECHA.
After the initial phase of 3 years, the resource requirement is reduced to maintain the infrastructure and the underlying processes and to continue providing data. This phase will require
- for ECHA, 4 FTEs (4 TAs) per year and operational budget of EUR 600 000 per year;
- for EEA, 1 FTE (1 TA) per year and operational budget of EUR 200 000 per year;
- for EFSA, 2 FTEs (2 CAs) per year and operational budget of EUR 500 000 per year;
- for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;
- for EMA, 2 FTEs (2 CAs) per year and operational budget of EUR 0.
The increases of the contributions to agencies will be compensated by a reduction of the LIFE budget except for 2 FTEs (2 CAs) for EFSA which will be compensated from EFSA’s current budget.
The proposal will formally establish the Information Platform for Chemical Monitoring (IPCHEM) and reattribute its operation to the Agencies. For this work,
- ECHA will need as of the second year 2 FTEs (1 TA + 1 CA) per year and as of the third year operational budget of EUR 180 000 per year;
- EEA will need as of the first year 1 FTE (1 TA) per year and the operational budget in the first year EUR 0, in the second year EUR 200 000, in the third year EUR 200 000 and as of the fourth year EUR 50 000 per year.
The operation of IPCHEM is currently done by the Commission and the resource use accounts for total of 4.5 FTEs/year. The operation of IPCHEM will be entrusted to ECHA which will also integrated it into the Common Data Platform. As the operation of IPCHEM will be reattributed to ECHA, the resources at the Commission’s side will be saved. Hosting of data will be entrusted to the Agencies based on their mandates (ECHA will host occupational data) and EEA will host indoor air data and collect and host human biomonitoring data. The proposal will require the agencies to provide occurrence data they hold to ECHA for the integration into IPCHEM. EFSA already provides data to IPCHEM and contributes to its operation and will not require any additional resources to continue in this activity. EMA and EU-OSHA currently do not systematically collect or receive data relevant for IPCHEM and therefore will not require any additional resources. The increase of the contribution to ECHA and EEA will be compensated by a reduction of the LIFE budget. It is therefore a partial redeployment of existing resources.
The proposal will establish a database containing information on regulatory processes on chemicals on the basis of existing (public) activities coordination tool ((P)ACT) and enlarging its scope to cover all relevant legislation with safety assessment processes and initiatives to promote coordination of safety assessment activities across EU legislation and provide transparency on the ongoing assessments. This work will impact ECHA, EEA, EFSA and EU-OSHA but will not require additional resources for the agencies. ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates OpenEFSA which has similar level of information as PACT for food and feed legislation. Resources for the operation and continuous provision of information are to be absorbed by the Agencies as part of the existing processes. EEA and EU-OSHA are currently not involved in any processes relevant for the database, therefore no resources are required for them. The development and coordination of the system is covered by the resources provided for the common data platform.
The proposal will establish a repository of reference values to promote the reuse of existing reference values and thus improve coherence of assessments and reduce repetition of deriving reference values. The proposal will impact ECHA, EEA, EFSA, EMA, EU-OSHA and the Commission. To perform the required work, ECHA will need as of the first year 1 FTE (1 TA) per year and operational budget of EUR 0 in the first year, EUR 650 000 in the second year, EUR 650 000 in the third year and as of the fourth year EUR 200 000 per year. No additional resources will be needed for EEA, EFSA, EMA, EU-OSHA or the Commission. ECHA has developed and operates the EU Chemicals Legislation Finder (EUCLEF). EUCLEF lists some regulatory reference values derived and applicable under these legislative pieces. ECHA will have to collate the ‘old scientific reference values’ which can be done via contracting. The new scientific reference values will be provided to the repository progressively as part of ECHA’s assessment processes. ECHA will require additional resources for developing, operating and maintain the repository, being in contact with data providers. EFSA has developed and is maintaining the OpenFoodTox database that summarises the scientific reference values derived by EFSA as part of its assessment activities. EFSA will continue its activity and will provide the information to the new repository as part of its existing resources. Therefore, no additional resources are required. EMA will need to provide to the new repository on continuous basis all new predicted no effect concentrations (PNECs) derived for human and veterinary medicinal products after entry into force of this legislation. This can be done efficiently as part of EMA’s future assessment activities. In addition, this can be automatized for human medicines as digitalisation of environmental risk assessment is foreseen as part of the revision of human medicinal product legislation. Therefore, no additional resources are required. EEA and EU-OSHA currently do not hold any relevant data for the repository. Therefore, no additional resources are required. The increase of the contribution to ECHA will be compensated by a reduction of the LIFE budget.
The proposal will formalise establishment and operation of a database with information on applicable laws and legal obligations applicable to chemicals under Union legislation to promote compliance. This work will impact ECHA but will not require additional resources under this proposal. ECHA already operates EU chemical legislative finder (EUCLEF) as part of the contribution agreement with DG GROW. The contribution agreement amounts to ca. EUR 1.0 – 1.4 million annually. ECHA runs the service through the employment of 4 interim staff members (ca. EUR 270 000/year) and via contractors: communication activities and external helpdesk ca. EUR 60 000/year, IT costs EUR 200 000/year, data costs EUR 430 000/year. These existing resources will be used to continue operating, further developing and slightly expanding the system. The resources for major extension of the system, such as the repository of reference values, are provided under the work on repository of reference values. Although no resources are required under this proposal, the legislative proposal for a regulation on ECHA should address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing should become part of the annual contribution to ECHA.
The proposal will establish a database on environmental sustainability related data on chemicals. The work will impact ECHA. ECHA will be required to set up the database, operate it, establish and maintain the flows of adequate data into the database and provide interpretation of data. Other agencies (EEA, EFSA, EMA and EU-OSHA), if they host environmental sustainable data on chemicals, will provide that data to ECHA and will cooperate as necessary with ECHA on the development. To perform the work, ECHA will need as of the second year 1 FTE (1 TA) per year and operational budget of EUR 0 per year. Other agencies will not need additional resources as their task is small, currently do not actively collect any relevant data, and if they have any of such data, the amount of information held is currently very limited. The potential work on cooperation in this area can be absorbed by the agencies’ current resources. The increase of the contribution to ECHA will be compensated by a reduction of the LIFE budget.
The proposal will establish data generation mechanism to allow ECHA and the Commission to commission studies supporting the implementation of Union chemicals legislation within ECHA’s mandate or contributing to the development of Union chemicals policy. The studies can be commissioned only when results cannot be obtained through existing legal provisions and they shall not have predominant research and development objective. The mechanism will allow ECHA and the Commission to generate data where needed and cannot be obtained otherwise. ECHA’s involvement is necessary as commissioning of such studies requires technical expertise. To perform the work, ECHA will require in the first year 1 FTE (1 TA) and operational budget of EUR 0, in the second year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 1 000 000, in the third year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 3 000 000 and as of the fourth year 2 FTEs (1 TA and 1 CA) per year and operational budget of EUR 5 000 000 per year. No current process exists, but there is a complementary process operated by EFSA for the food sector (4 FTEs/year, EUR 15 000 000/year). This will continue to be operated next to the new one and the two Agencies (ECHA and EFSA) are required to cooperate when commissioning such studies and develop a joint plan. The increase of the contribution to ECHA will be compensated by a reduction of the LIFE budget.
The proposal will expand the obligation to notify studies before they start from food sector to all chemical sector. The work will require additional resource for ECHA. ECHA will need as of the first year 3 FTEs (1 TA and 2 CAs) per year and operational budget in the first year of EUR 0, in the second year EUR 1 200 000, in the third year EUR 400 000 and as of the fourth year EUR 200 000 per year. ECHA will be required to develop the database, operate it, facilitate and check compliance with the provisions and provide feedback to the duty holders. EFSA already operates a database of notification of studies to serve the obligation under the food sector legislation. The resource use amounts to 2 FTEs/year and EUR 400 000/year. EFSA and ECHA will be required to ensure compatibility of the systems. No additional resources are needed for this for EFSA. The increased contribution to ECHA will be compensated by a reduction of the LIFE budget.
The proposal will formalise the operation of the indicators framework for chemicals and will establish an early warning and action system for chemicals. The work will require additional resources for EEA. EEA will need as of the first year 1 FTE (1 TA) per year and operational budget for the first year of EUR 0, for the second year EUR 300 000 and as of the third year EUR 150 000 per year. EEA and ECHA already jointly develop the indicators framework for chemicals as part of the commitment under the 8th Environment Action Programme. As the resources for indicator framework (2 FTEs per year for ECHA, 1 FTE per year for EEA) were already attribution as part of the 8th EAP, no additional resources are needed for this work. The establishment of the early warning and action system is a new, non-existing task that aims to significantly shorten the regulatory response to identified risks. The EEA will be tasked to collect early warning signals from other agencies, Member State and by its own activity and compile annually a report for discussion and decision on the follow up with Member States authorities. The increased contribution to EEA will be compensated by a reduction of the LIFE budget. Other contributing agencies (ECHA, EFSA, EMA and EU-OSHA) will absorb the costs as part of exiting activities. In case of ECHA, the resources attribution for the indicator framework will be partly used to support the EEA by generating relevant early warning signals. The increased contribution to EEA will be compensated by a reduction of the LIFE budget.
The proposal will establish an observatory for specific chemicals with potential contribution to emerging chemical risks. This will de facto formalise the operation of existing EU Observatory for nanomaterials and extend its scope to specific chemicals considered to benefit from additional scrutiny and reliable information on their properties, safety aspects, uses and market presence. This work will impact ECHA but will not require additional resources under this proposal. ECHA operates the EU Observatory for nanomaterials as part of a contribution agreement with DG GROW. The resource use amounts to approximately EUR 700 000 per year including the 3 FTEs (3 CA). These existing resources will be used to continue operating, further developing and slightly expanding the system. The legislative proposal in preparation for a regulation on ECHA will address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing should become part of the annual contribution to ECHA.
| Resource needs per activity for the proposal for a Regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Activity | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| Common data platform | 5 | 16 | 5 | 16 | 5 | 16 | 950 | 3 442 | 4 077 |
| Information Platform for Chemical Monitoring (IPCHEM) | 1 | 0 | 2 | 1 | 2 | 1 | 0 | 200 | 380 |
| Information on regulatory processes on chemicals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Repository of reference values | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 650 | 650 |
| Information on the obligations under Union acts on chemicals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Environmental sustainability related data on chemicals | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Data generation mechanism | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 000 | 3 000 |
| Mechanism for notification of studies and database for study notifications | 1 | 2 | 1 | 2 | 1 | 2 | 0 | 1 200 | 400 |
| Early warning and action system for emerging chemical risks and framework of indicators | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 300 | 150 |
| Observatory for specific chemicals with potential contribution to emerging chemical risks | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SUM | 10 | 18 | 12 | 20 | 12 | 20 | 950 | 6 792 | 8 657 |
| Resource needs per agency/service for the proposal for a Regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | ||||
| Agency / Service | TA | CA | TA | CA | TA | CA | |||
| ECHA | 7 | 8 | 9 | 10 | 9 | 10 | 0 | 5 076 | 7 023 |
| EEA | 3 | 2 | 3 | 2 | 3 | 2 | 0 | 766 | 684 |
| EFSA | 0 | 5 | 0 | 5 | 0 | 5 | 670 | 670 | 670 |
| EMA | 0 | 3 | 0 | 3 | 0 | 3 | 100 | 100 | 100 |
| EU OSHA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| JRC | 0 | 0 | 0 | 0 | 0 | 0 | 180 | 180 | 180 |
| SUm | 10 | 18 | 12 | 20 | 12 | 20 | 950 | 6 792 | 8 657 |
| Current resource use for technical and scientific work to be reattributed to Agencies as part of the proposal for a Regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals | |
| IPCHEM | Total 4.5 FTEs/year: DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 130 000 per year). |
| Information on regulatory processes on chemicals | ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates OpenEFSA which has a similar level of information as PACT. Resources for the operation and continuous provision of information are to be absorbed by the Agencies. |
| Information on the obligations under Union acts on chemicals | ECHA already operates EUCLEF and this is financed through the contribution agreement between DG GROW and ECHA. No additional resources needed but the formalisation of the resource allocation should be done by the proposal for regulation on ECHA. |
| Observatory for specific chemicals with potential contribution to emerging chemical risks | ECHA already operates the EU Observatory on Nanomaterials and this is financed via the contribution agreement between DG GROW and ECHA. No additional resources needed but the formalisation of the resource allocation should be done by the proposal for a regulation on ECHA. |
| SUm | 2.5 FTEs/year of regular staff; 2 FTEs/year of intramurous contractors or interim staff (ca. EUR 130 000/year) |
In summary, the legislative proposal on chemicals data consists of 10 distinct activities that will have an impact on resource needs of ECHA, EEA, EFSA, EMA and the Commission. The first three years there will be a need of up to 32 FTEs (12 TA + 20 CA) per year and an operational budget of up to EUR 8 657 000 per year. In the fourth year and beyond, there will be a need of 20 FTEs (12 TA and 8 CA) per year and an operational budget of EUR 7 080 000 per year. It must be noted that some activities included in the calculation above already exists and are financed as part of existing core ECHA and EFSA work (such as (P)ACT), through the contribution agreements between GROW and ECHA (EUCLEF and EU Observatory for nanomaterials) or from JRC core activities (IPCHEM). Resources for the operation of (P)ACT and OpenEFSA portal that should feed into the extended version of (P)ACT will be used to absorb the expansion of the (P)ACT for other pieces of legislation, including the merge of OpenEFSA into (P)ACT. Resources for the operation of EUCLEF and EUON will be used to continue operation, development and slight expansion of the systems, while the fact that that the operation of the EUCLEF and EUON became a structural task for ECHA and that there is a need to ensure that the financing should be part of the annual contribution to ECHA will be addressed in the proposal for a regulation on ECHA. Therefore for this part of work no additional resources are required under this proposal. The resources currently used for the operation of IPCHEM consists of 2.5 FTEs/year of regular staff, 2 FTEs of intramurous contractors (EUR 130 000 per year). As this task will be reattributed, the current resources used for this task will not be needed by the Commission. Therefore, the total net increase in the resources from 2028 and beyond as compared to today will be 15.5 FTEs per year and operational budget of EUR 7 080 000 per year.
| Resource needs for ECHA for proposal for a Regulation on packaging and packaging waste (COM (2022) 677 final) | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Legislation | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| Packaging and packaging waste | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| SUM | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
Proposal for a directive amending waste framework directive (COM (2023) 420 final):
| Resource needs for EEA for proposal for a Directive amending waste framework directive (COM (2023) 420 final) | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Legislation | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| Waste framework directive | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| SUM | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
Proposal for a Regulation on circularity requirements for vehicle design and on management of end-of-life vehicles (COM (2023) 451 final):
ECHA support is required for improving the risk assessment of the remaining hazardous substance exemptions, in particular for reviewing the scope extension and potential wider coverage of substances of concern (1 FTE (1 TA) per year for ECHA). The increased contribution to ECHA will be compensated by a reduction of the LIFE budget.
| Resource needs for ECHA for proposal for a Regulation on circularity requirements for vehicle design and on management of end-of-life vehicles (COM (2023) 451 final) | |||||||||
| FTEs | Operational costs (in EUR 1 000) | ||||||||
| Legislation | 2025 | 2026 | 2027 | 2025 | 2026 | 2027 | |||
| TA | CA | TA | CA | TA | CA | ||||
| End-of-life vehicles regulation | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| SUM | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
1.6.Duration and financial impact of the proposal/initiative
limited duration
– in effect from [DD/MM]YYYY to [DD/MM]YYYY
– Financial impact from YYYY to YYYY for commitment appropriations and from YYYY to YYYY for payment appropriations.
unlimited duration
–Implementation with a start-up period from 2025 to 2028,
–followed by full-scale operation.
1.7.Method(s) of budget implementation planned 61
Direct management by the Commission
– by its departments, including by its staff in the Union delegations;
– by the executive agencies
Shared management with the Member States
Indirect management by entrusting budget implementation tasks to:
– third countries or the bodies they have designated;
– international organisations and their agencies (to be specified);
– the EIB and the European Investment Fund;
– bodies referred to in Articles 70 and 71 of the Financial Regulation;
– public law bodies;
– bodies governed by private law with a public service mission to the extent that they are provided with adequate financial guarantees;
– bodies governed by the private law of a Member State that are entrusted with the implementation of a public-private partnership and that are provided with adequate financial guarantees;
– bodies or persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.
–If more than one management mode is indicated, please provide details in the ‘Comments’ section.
2. MANAGEMENT MEASURES
2.1.Monitoring and reporting rules
Specify frequency and conditions.
This Legislative Financial Statement includes an increase of the contribution to the ECHA and the EEA, and contribution/service level agreements with the EFSA and the EMA.
The Commission will be overall accountable for implementing the proposed Regulation as well as for reporting to the European Parliament and the Council on implementation and compliance. The agencies will report on the implementation of their contributions and of the related actions in their annual activity reports.
2.2.Management and control system(s)
2.2.1.Justification of the management mode(s), the funding implementation mechanism(s), the payment modalities and the control strategy proposed
This Legislative Financial Statement includes an increase of the contribution to the ECHA and the EEA, and contribution/service level agreements with the EFSA and the EMA.
DG Environment, in the context of its supervision of decentralised entities, and the agencies will apply its respective control strategies to this expenditure.
2.2.2.Information concerning the risks identified and the internal control system(s) set up to mitigate them
While the Commission will be overall accountable for implementing the proposed Regulation as well as for reporting to the European Parliament and the Council on the implementation and compliance, the additional resources put at the disposal of the agencies will be covered by their internal control and risk management systems that are aligned with the relevant international standards. DG Environment will apply the controls related to its supervision of decentralised agencies. No specific risks are identified in relation with the implementation of the additional budget to be provided to the agencies.
2.2.3.Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure)
The risk of error at payment and at closure is expected to remain under 2%. The agencies are full responsibility over the implementation of their budget, while DG Environment is responsible for the regular payment of the contributions.
2.3.Measures to prevent fraud and irregularities
Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy.
In addition to the controls stemming from the control strategie listed above, the action is subject to scrutiny of the Internal Audit Service, in its capacity of internal auditor of the Commission and of the decentralised agencies, and of the European Court of Auditors, in its capacity of external auditor of the EU Institutions.
The Commission maintains robust antifraud strategy, the CAFS, that is currently under revision. DG Environment complements this by a local antifraud strategy that covers the activities falling under its remit.
3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1.Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
·Existing budget lines
In order of multiannual financial framework headings and budget lines.
| Heading of multiannual financial framework | Budget line | Type of expenditure | Contribution | |||
| Number | Diff./Non-diff. 62 | from EFTA countries 63 | from candidate countries and potential candidates 64 | fromother third countries | other assigned revenue | |
| 3 | 09.0202 – LIFE Circular Economy and Quality of Life | Diff | YES | YES | NO | NO |
| 3 | 09.10.01 European Chemicals Agency – environmental directives and international conventions | Diff | YES | NO | NO | NO |
| 3 | 09.10.02 European Environment Agency (ENV) | Diff | YES | YES | YES | NO |
·New budget lines requested
In order of multiannual financial framework headings and budget lines.
N/A
3.2.Estimated financial impact of the proposal on appropriations
3.2.1.Summary of estimated impact on operational appropriations
– The proposal/initiative does not require the use of operational appropriations
– The proposal/initiative requires the use of operational appropriations, as explained below:
EUR million (to three decimal places)
| Heading of multiannual financial framework | Number | Heading 3 (Natural resources and environment) |
| Agency: ECHA – Environmental Directives | 2024 | 2025 | 2026 | 2027 | TOTAL | ||
| Title 1: Staff expenditure | Commitments | (1a) | 0 | 1,765 | 4,991 | 5,091 | 11,848 |
| Payments | (2a) | 0 | 1,765 | 4,991 | 5,091 | 11,848 | |
| Title 2: Infrastructure | Commitments | (1b) | |||||
| Payments | (2b) | ||||||
| Title 3: Operational expenditure | Commitments | (1c) | 0 | 0,101 | 5,159 | 7,106 | 12,366 |
| Payments | (2c) | 0 | 0,101 | 5,159 | 7,106 | 12,366 | |
| TOTAL appropriations for agency ECHA | Commitments | =1a + 1b + 1c | 0 | 1,866 | 10,150 | 12,197 | 24,214 |
| Payments | =2a + 2b + 2c | 0 | 1,866 | 10,150 | 12,197 | 24,214 |
The details of the tasks to be performed by ECHA are specified in the staff working document 65 accompanying this legal proposal, in particular in the Annexes III and IV. The above increase of the contribution to ECHA will be offset from the LIFE Programme (budget line: 09.02.02).
| Agency: EEA | 2024 | 2025 | 2026 | 2027 | TOTAL | ||
| Title 1: Staff expenditure | Commitments | (1a) | 0 | 0,595 | 1,214 | 1,238 | 3,046 |
| Payments | (2a) | 0 | 0,595 | 1,214 | 1,238 | 3,046 | |
| Title 2: Infrastructure | Commitments | (1b) | |||||
| Payments | (2b) | ||||||
| Title 3: Operational expenditure | Commitments | (1c) | 0 | 0 | 0,766 | 0,684 | 1,450 |
| Payments | (2c) | 0 | 0 | 0,766 | 0,684 | 1,450 | |
| TOTAL appropriations for agency EEA | Commitments | =1a + 1b + 1c | 0 | 0,595 | 1,980 | 1,922 | 4,496 |
| Payments | =2a + 2b + 2c | 0 | 0,595 | 1,980 | 1,922 | 4,496 |
The details of the tasks to be performed by EEA are specified in the staff working document 66 accompanying this legal proposal, in particular in the Annexes III and IV. The above increase of the contribution to the EEA will be offset from the LIFE Programme (budget line: 09.02.02).
| DG: ENV | Budget line: 09.02.02 | 2024 | 2025 | 2026 | 2027 | TOTAL | |
| Contribution/Service level agreement with EFSA | Commitments | (1a) | - | 1,000 | 1,000 | 1,000 | 3,000 |
| Payments | (2a) | - | 1,000 | 1,000 | 1,000 | 3,000 | |
| Contribution/Service level agreement with EMA | Commitments | (1b) | - | 0,467 | 0.467 | 0.467 | 1,400 |
| Payments | (2b) | - | 0,467 | 0.467 | 0.467 | 1,400 | |
| Administrative arrangements with JRC | Commitments | (1b) | - | 0,180 | 0,180 | 0,180 | 0,540 |
| Payments | (2b) | - | 0,180 | 0,180 | 0,180 | 0,540 | |
□ TOTAL operational appropriations | Commitments | (4) | - | 1,580 | 1,580 | 1,580 | 4,740 |
| Payments | (5) | - | 1,580 | 1,580 | 1,580 | 4,740 | |
| □ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes | (6) | ||||||
| TOTAL appropriations for DG ENV | Commitments | =4+ 6 | - | 1,647 | 1,647 | 1,647 | 4,940 |
| Payments | =5+ 6 | - | 1,647 | 1,647 | 1,647 | 4,940 |
The need for additional resources for EFSA is estimated at 3 contract agents and EUR 2 million of operational expenditure. The need for additional resources for EMA is estimated at 3 contract agents and EUR 0,3 million of operational expenditure. For 2025-2027, these costs will be covered through a contribution/service level agreement between the agencies and DG ENV. Without prejudice to the future MFF agreement, the costs from 2028 on should be covered by the EU subsidies to these agencies.
In addition, the need for additional resources for JRC is estimated at EUR 0,540 million of operational expenditure, to be channelled through an administrative agreement.
| 2024 | 2025 | 2026 | 2027 | TOTAL | |||
| □ TOTAL operational appropriations (all operational headings) | Commitments | (4) | |||||
| Payments | (5) | ||||||
| TOTAL appropriations of an administrative nature financed from the envelope for specific programmes (all operational headings) | (6) | ||||||
| TOTAL appropriations under HEADINGS 1 to 6 of the multiannual financial framework (Reference amount) | Commitments | =4+ 6 | 0 | 4,108 | 13,777 | 15,766 | 33,650 |
| Payments | =5+ 6 | 0 | 4,108 | 13,777 | 15,766 | 33,650 |
Heading of multiannual financial framework | 7 | ‘Administrative expenditure’ |
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex 5 to the Commission decision on the internal rules for the implementation of the Commission section of the general budget of the European Union), which is uploaded to DECIDE for interservice consultation purposes.
EUR million (to three decimal places)
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL | ||||
| DG: <…….> | |||||||||
| □ Human resources | |||||||||
| □ Other administrative expenditure | |||||||||
| TOTAL DG <…….> | Appropriations |
| TOTAL appropriations under HEADING 7 of the multiannual financial framework | (Total commitments = Total payments) |
EUR million (to three decimal places)
| 2024 | 2025 | 2026 | 2027 | TOTAL | |||
| TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework | Commitments | 0 | 4,108 | 13,777 | 15,766 | 33,650 | |
| Payments | 0 | 4,108 | 13,777 | 15,766 | 33,650 |
3.2.2.Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs | Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL | ||||||||||||
| OUTPUTS | ||||||||||||||||||
| Type 67 | Average cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | |
| SPECIFIC OBJECTIVE No 1 68 … | ||||||||||||||||||
| - Output | ||||||||||||||||||
| - Output | ||||||||||||||||||
| - Output | ||||||||||||||||||
| Subtotal for specific objective No 1 | ||||||||||||||||||
| SPECIFIC OBJECTIVE No 2 ... | ||||||||||||||||||
| - Output | ||||||||||||||||||
| Subtotal for specific objective No 2 | ||||||||||||||||||
| TOTALS |
3.2.3.Estimated impact on ECHA, EEA, EFSA and EMA human resources and administrative appropriations
3.2.3.1.Estimated requirements on ECHA’s human resources
– The proposal/initiative does not require the use of human resources.
– The proposal/initiative requires the use of human resources, as explained below:
EUR million (to three decimal places)
Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and charges).
| 2023 | 2024 | 2025 | 2026 | 2027 | TOTAL |
| Temporary agents (AD Grades) | - | - | 1,330 | 3,548 | 3,619 | 8,496 |
| Temporary agents (AST grades) | - | - | - | - | - | - |
| Contract staff | - | - | 0,436 | 1,444 | 1,473 | 3,352 |
| Seconded National Experts | - | - | - | - | - | - |
| TOTAL | - | - | 1,765 | 4,991 | 5,091 | 11,848 |
Staff requirements (FTE):
| 2023 | 2024 | 2025 | 2026 | 2027 | TOTAL |
| Temporary agents (AD Grades) | - | - | 13 | 17 | 17 | |
| Temporary agents (AST grades) | - | - | - | - | - | |
| Contract staff | - | - | 8 | 13 | 13 | |
| Seconded National Experts | - | - | - | - | - |
| TOTAL | - | - | 21 | 30 | 30 |
3.2.3.2.Estimated requirements on EEA’s human resources
– The proposal/initiative does not require the use of human resources.
– The proposal/initiative requires the use of human resources, as explained below:
EUR million (to three decimal places)
Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and charges).
| 2023 | 2024 | 2025 | 2026 | 2027 | TOTAL |
| Temporary agents (AD Grades) | - | - | 0,470 | 0,959 | 0,978 | 2,406 |
| Temporary agents (AST grades) | - | - | - | - | - | - |
| Contract staff | - | - | 0,125 | 0,255 | 0,260 | 0,640 |
| Seconded National Experts | - | - | - | - | - |
| TOTAL | 0,595 | 1,214 | 1,238 | 3,046 |
Staff requirements (FTE):
| 2023 | 2024 | 2025 | 2026 | 2027 | TOTAL |
| Temporary agents (AD Grades) | - | - | 4 | 4 | 4 | |
| Temporary agents (AST grades) | - | - | - | - | - | |
| Contract staff | - | - | 2 | 2 | 2 | |
| Seconded National Experts | - | - | - | - | - |
| TOTAL | 6 | 6 | 6 |
3.2.3.3.Estimated requirements on EMA’s human resources
– The proposal/initiative does not require the use of human resources.
– The proposal/initiative requires the use of human resources, as explained below:
Staff requirements (FTE):
| 2025 | 2026 | 2027 |
| Temporary agents (AD Grades) | - | ||
| Temporary agents (AST grades) | - | - | - |
| Contract staff | 3 | 3 | 3 |
| Seconded National Experts | - | - | - |
| TOTAL | 3 | 3 | 3 |
3.2.3.4.Estimated requirements on EFSA’s human resources
– The proposal/initiative does not require the use of human resources.
– The proposal/initiative requires the use of human resources, as explained below:
Staff requirements (FTE):
| 2025 | 2026 | 2027 |
| Temporary agents (AD Grades) | - | ||
| Temporary agents (AST grades) | - | - | - |
| Contract staff | 5 | 5 | 5 |
| Seconded National Experts | - | - | - |
| TOTAL | 5 | 5 | 5 |
3.2.4.Compatibility with the current multiannual financial framework
The proposal/initiative:
– can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
The increases of the agencies subsidies will be offset from the LIFE programme except 2 FTEs (2 CAs) for EFSA which will be financed from EFSA’s current budget as detailed above.
– requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
– requires a revision of the MFF.
3.2.5.Third-party contributions
The proposal/initiative:
– does not provide for co-financing by third parties
– provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year N 69 | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3.Estimated impact on revenue
– The proposal/initiative has no financial impact on revenue.
– The proposal/initiative has the following financial impact:
– on own resources
– on other revenue
–please indicate, if the revenue is assigned to expenditure lines
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative 70 | ||||||
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
(1)
Commission Staff Working Document Fitness Check of the most relevant chemicals legislation (excluding REACH), as well as related aspects of legislation applied to downstream industries 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: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses ( SWD(2019) 199 ).
(2) The European Green Deal. COM (2019) 640 final.
(3) The Chemicals Strategy for Sustainability COM (2020) 667 final .
(4) Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021 .
(5) European Parliament resolution of 10 July 2020 on the Chemicals Strategy for Sustainability (2020/2531(RSP)) ( OJ C 371, 15.9.2021, p.75 ).
(6) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Pathway to a Healthy Planet for All - EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' ( COM(2021) 400 final ).
(7) Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169 25.6.2019, p. 45 ).
(8) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117 5.5.2017, p. 1 ).
(9) Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network ( OJ L 126 21.5.2009, p. 13).
(10) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 031 1.2.2002, p. 1 ).
(11) OJ L 435 23.12.2020, p. 1 .
(12) OJ L 314 6.12.2022, p. 26 .
(13) COM(2020) 798 final .
(14) COM(2022) 157 final .
(15) COM(2022) 156 final/3
(16) COM(2022) 540 final .
(17) COM(2022) 748 final .
(18) COM(2022) 677 final .
(19) COM/2023/451 final .
(20) COM(2023) 462 final .
(21) OJ L 272 20.10.2022, p. 14 .
(22) European Chemicals Agency – proposal for a basic regulation (europa.eu)
(23) Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu)
(24) EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)
(25)
COM/2023/193 final .
(26)
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011,
p. 88).
(27) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006 , p.1 ).
(28) Proposal for a Regulation of the European Parliament and the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals (COM(2023) 779)
(29) Commission staff working document accompanying the documents Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals and Proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency (SWD (2023) 850)
(30)
Report from the Commission to the European Parliament, the Council, the European Economic And Social Committee and the Committee of the Regions: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses ( COM/2019/264 final ).
(31) Register of Commission expert groups and other similar entities (europa.eu) .
(32) European Chemicals Agency – proposal for a basic regulation (europa.eu)
(33) SWD (2023) 850
(34) SWD (2023) 850
(35) SWD (2023) 850
(36) COM (2022) 677 final .
(37) COM (2023) 420 final .
(38) COM (2023) 451 final .
(39) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ).
(40) Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network ( OJ L 126, 21.5.2009, p. 13 ).
(41) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ).
(42) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).
(43) Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.6.2019, p. 45 ).
(44) Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal. COM (2019) 640 final .
(45) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. COM (2020) 667 final
(46) Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency.
(47) Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM(2023) 193 final . [OJ:Please insert correct reference once the Regulation is adopted].
(48) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ) .
(49) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1–849 ).
(50) Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures ( OJ L 93, 31.3.2023, p. 7–39 ).
(51) Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.6.2019, p. 45 ) .
(52) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), ( OJ L 435, 23.12.2020, p. 1–62 ).
(53) [OJ Please insert reference once proposal is adopted]
(54) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353 31.12.2008, p. 1 – 1355 .
(55) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006( OJ L 353 31.12.2008, p. 1 ) .
(56) As referred to in Article 58(2)(a) or (b) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (Financial Regulation). OJ L 193 30.7.2018, p. 1 – 222 .
(57) Commission staff working document accompanying the document Proposal for a Regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals (COM (2023) 855).
(58) 8th Environmental Action Plan (EAP) monitoring framework. COM (2022) 357 final.
(59)
Report from the Commission to the European Parliament, the Council, the European Economic And Social Committee and the Committee of the Regions: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses. COM/2019/264 final .
(60) EEA: Late lessons from early warnings: the precautionary principle 1896–2000, Luxembourg: Office for Official Publications of the European Communities, 2001
(61) Details of budget implementation methods and references to the Financial Regulation may be found on the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-implementation/Pages/implementation-methods.aspx
(62) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(63) EFTA: European Free Trade Association.
(64) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(65) SWD (2023) 850
(66) SWD (2023) 850
(67) Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(68) As described in point 1.4.2. ‘Specific objective(s)…’
(69) Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
(70) As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.