Annexes to COM(2021)346 - General product safety

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This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2021)346 - General product safety.
document COM(2021)346 EN
date May 10, 2023
agreements financing the implementation of this Regulation will expressly entitle the Commission, including OLAF and the Court of Auditors to conduct audits, on-the-spot checks and inspections.

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 frameworkBudget lineType of
expenditure
Contribution
NumberDiff./Non-diff. 51from EFTA countries 52

from candidate countries 53

from third countrieswithin the meaning of Article 21(2)(b) of the Financial Regulation
103.020401Diff.YESNONONO

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 1
DG: JUSTYear
2024 54
Year
2025
Year
2026
Year
2027
Enter as many years as necessary to show the duration of the impact (see point 1.6)TOTAL
• Operational appropriations
Post 2027
Budget line 55  03.020401Commitments(1a)7,0007,0007,0007,00028,000
Payments(2a)2,1007,0007,0007,0004,90028,000
Appropriations of an administrative nature financed from the envelope of specific programmes 56  

Budget line 03010101(3)0,2000,2000,2000,2000,800
TOTAL appropriations
for DG JUST 
Commitments=1a+1b +37,2007,2007,2007,20028,800
Payments=2a+2b

+3
2,3007,2007,2007,2004,90028,800


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 V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.

EUR million (to three decimal places)

Year
2024
Year
2025
Year
2026
Year
2027
Enter as many years as necessary to show the duration of the impact (see point 1.6)TOTAL
DG: JUST
• Human resources
3,0543,0543,0543,05412,216 
• Other administrative expenditure
0,0950,0950,0950,0950,380 
TOTAL DG JUSTAppropriations3,1493,1493,1493,14912,596

TOTAL appropriations
under HEADING 7
of the multiannual financial framework 
(Total commitments = Total payments)3,1493,1493,1493,14912,596

EUR million (to three decimal places)

Year
2024 57
Year
2025
Year
2026
Year
2027
Enter as many years as necessary to show the duration of the impact (see point 1.6)TOTAL
TOTAL appropriations
under HEADINGS 1 to 7
of the multiannual financial framework 
Commitments10,34910,34910,34910,34941,396
Payments5,44910,34910,34910,3494,90041,396

3.2.2.Estimated output funded with operational appropriations 

Commitment appropriations in EUR million (to three decimal places)

Indicate objectives and outputs



Year
2024
Year
2025
Year
2026
Year
2027
Enter as many years as necessary to show the duration of the impact (see point 1.6)TOTAL
OUTPUTS
Type 58

Average costNoCostNoCostNoCostNoCostNoCostNoCostNoCostTotal NoTotal cost
SPECIFIC OBJECTIVE No 1 59Reinforcing market surveillance cooperation procedures among enforcement authorities, reducing fragmentation and inefficiencies
Coordinated activities for the safety of productactivities0,300103,000103,000103,000103,0004012,000
Studies, peer reviews, piloting national products safety strategiesreports0,20020,40020,40020,40020,40081,600
Subtotal for specific objective No 1123,400123,400123,400123,4004813,600
SPECIFIC OBJECTIVE No 2 ...Increasing operational capacity, improving efficiency and availability of resources for coordination of enforcement and implementation of the proposal (monitoring, delegated acts), increasing the use of standardisation procedure
Implementation of the proposal (delegated acts, monitoring, standardisation)
Subtotal for specific objective No 2
SPECIFIC OBJECTIVE No 3Strengthening the enforcement toolbox, allowing market surveillance authorities to use more deterrent, effective and future-proof tools
Big data and other innovative tools in online market surveillance and product safety -data collec. IT tools0,12520,25020,25020,25020,2501,000
Subtotal for specific objective No 320,25020,25020,25020,2501,000
SPECIFIC OBJECTIVE No 4Improving the exchange of information on dangerous products both inside the EU and with external partners (including via IT tools). Improving information to businesses and consumers on dangerous products via IT tools
Safety Gate galaxyIT systems0,16691,50091,50091,50091,5006,000
Exchange of data with international partners and other international cooperationLinkage with other systems0.3531,05031,05031,05031,0504,200
Subtotal for specific objective No 4122,550122,550122,550122,55010,200
SPECIFIC OBJECTIVE No 5Promoting compliance with EU product safety legislation on non-harmonised consumer products.
Promotion and communication activitiesConferences, press, campaign0,240,80040,80040,80040,8003,200
Subtotal for specific objective No 540,80040,80040,80040,8003,200
TOTALS7,0007,0007,0007,00028,000

3.2.3.Summary of estimated impact on administrative appropriations 

–◻    The proposal/initiative does not require the use of appropriations of an administrative nature

–☒    The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:

EUR million (to three decimal places)

Year
2024 60
Year
2025
Year
2026
Year
2027
Enter as many years as necessary to show the duration of the impact (see point 1.6)TOTAL

HEADING 7
of the multiannual financial framework
Human resources3,0543,0543,0543,05412,216
Other administrative expenditure0,0950,0950,0950,0950,380 
Subtotal HEADING 7
of the multiannual financial framework
3,1493,1493,1493,14912,596
TOTAL3,1493,1493,1493,14912,596


The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.

3.2.3.1.Estimated requirements of 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:

Estimate to be expressed in full time equivalent units

Year
2024
Year
2025
Year 2026Year 2027Enter as many years as necessary to show the duration of the impact (see point 1.6)
• Establishment plan posts (officials and temporary staff)
20 01 02 01 (Headquarters and Commission’s Representation Offices)18181818
20 01 02 03 (Delegations)
01 01 01 01 (Indirect research)
01 01 01 11 (Direct research)
Other budget lines (specify)
• External staff (in Full Time Equivalent unit: FTE) 61

20 02 01 (AC, END, INT from the ‘global envelope’)5555
20 02 03 (AC, AL, END, INT and JPD in the delegations)
XX 01 xx yy zz 62

- at Headquarters

- in Delegations
01 01 01 02 (AC, END, INT - Indirect research)
01 01 01 12 (AC, END, INT - Direct research)
Other budget lines (specify)
TOTAL23232323

XX is the policy area or budget title concerned.

The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.

Description of tasks to be carried out:

Officials and temporary staffPreparation of delegated acts (related to traceability and recalls), set-up the new cooperation activities (new arbitration mechanism, peer reviews, cooperation with the Union Product Compliance Network), pilot national product safety enforcement strategies, improving interlinks with other databases (ICSMS, customs), international cooperation and monitoring of the Regulation. Preparation of implementing acts for the standardisation activities.

AD staff for product safety and market surveillance, technical and legal analysis, joint actions management, specific market surveillance expertise, project management, Safety Gate coordination and implementation, international cooperation, the Secretariat of the Consumer Safety Network, communication and promotion activities, IT and data-systems supervision and financial management tasks.

AST staff for support to meeting organisation and all administrative tasks.
External staffRoutine IT maintenance and specific development projects –.

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).

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts. Please provide an excel table in the case of major reprogramming.

No reprogramming is required.

–◻    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.

Explain what is required, specifying the headings and budget lines concerned, the corresponding amounts, and the instruments proposed to be used.

–◻    requires a revision of the MFF.

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.

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 63
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 yearImpact of the proposal/initiative 64
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) Communication from the Commission to the European Parliament and the Council, New Consumer Agenda – Strengthening consumer resilience for sustainable recovery, COM(2020) 696 final.
(2) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance),) OJ L 11, 15.1.2002, p. 4.
(3) Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions, Single Market Act – Twelve levers to boost growth and strengthen confidence – Working together to create new growth/* COM/2011/0206 final.
(4) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance), )OJ L 218, 13.8.2008, p. 30.
(5) Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions, Upgrading the Single Market: more opportunities for people and business, COM/2015/0550 final.
(6) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1.
(7) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011, OJ L 169, 25.6.2019, p. 1.
(8) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance),) OJ L 218, 13.8.2008, p. 82.
(9) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council, L 316, 14.11.2012, p. 12.
(10) Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (Text with EEA relevance),.) OJ L 136, 22.5.2019, p. 28.
(11) Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act), OJ L 151, 7.6.2019, p. 15. 
(12) Proposal for a regulation of the European Parliament and of the Council on a Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC, COM/2020/825 final.
(13) Communication from the Commission to the European Parliament and 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.
(14) 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.
(15) Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions A new Circular Economy Action Plan For a cleaner and more competitive Europe COM/2020/98 final.
(16) Article 169 makes reference to Article 114 to achieve its objectives.
(17) Also, product safety is part of the high level of consumer protection ensured by EU policies (see Article 38 of the Charter of Fundamental Rights of the European Union) and is therefore one of the pillars of EU consumer protection policy.
(18) Traders trying different entry points to the EU.
(19) Please see the opinion of the Sub-group on Artificial Intelligence (AI), connected products and other new challenges in product safety to the Consumer Safety Network of December 2020.
(20) Feedbacks received on the roadmap: General Product Safety Directive – review (europa.eu)
(21) .OJ C , , p. .
(22) Directive 2001/95/EC of the European Parliament and of the Council on general product safety (OJ L 11, 15.1.2002, p. 4).
(23) Council Directive 87/357/EEC of 25 June on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (OJ L 192, 11.7. 1987, p. 49).
(24) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). 
(25) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). 
(26) European Environment Agency, ‘Healthy environment, healthy lives: how the environment influences health and well-being in Europe’, EEA report No 21/2019, 8 September 2020.
(27) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
(28) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1–122).
(29) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') - OJ L 178, 17.7.2000, p. 1–16.
(30) Regulation […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC.
(31) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
(32) Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22. 5. 2019, p. 28).
(33) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14. 11. 2012, p. 12).
(34) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(35) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(36) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(37) OJ L 123, 12.5.2016, p. 1.
(38)    …
(39) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21. 1. 1998, p. 14).
(40) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2. 5. 2018, p. 19).
(41) Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, p. 121).
(42) 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 (OJ L 193, 30.7.2018, p. 1).
(43) OJ L292, 14.11.1996, p.2.
(44) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(45) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(46) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(47) OJ L 123, 12.5.2016, p. 1
(48) Regulation (EU) …/… of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council (OJ …)’
(49) As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
(50) Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx  
(51) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(52) EFTA: European Free Trade Association.
(53) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(54) 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.
(55) According to the official budget nomenclature.
(56) Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(57) 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.
(58) Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(59) As described in point 1.4.2. ‘Specific objective(s)…’
(60) 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.
(61) AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
(62) Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
(63) 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.
(64) 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.