Annexes to COM(2018)116 - Commission General Report on the operation of REACH and review of certain elements - Conclusions and Actions - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2018)116 - Commission General Report on the operation of REACH and review of certain elements - Conclusions and Actions. |
|---|---|
| document | COM(2018)116  |
| date | March 5, 2018 |
2.4.ECHA
ECHA has been instrumental in the implementation of REACH and has now built up a significant competence in chemicals management. ECHA has established a user-friendly website enabling stakeholders to easily access the world's largest database on chemicals. ECHA has also established scientific cooperation with the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA), as well as with other non-EU agencies, which should be further reinforced to ensure coherence and profit from synergies.
Around 2020, the fee income of ECHA will be substantially reduced 24 and the Commission will need to assess how to maintain ECHA's expertise and independence, including the scrutiny of working methods of the committees and mitigation of conflicts of interest.
2.5.Potential for simplification and burden reduction
Overall, the REACH evaluation has not identified unnecessary legal requirements and obligations given the needs and objectives pursued. There is a margin for simplification and burden reduction in the way those requirements are implemented and in particular for clarifying how they are to be fulfilled by the duty holders. However, simplification should not incur reductions in the level of protection of human health and the environment.
Some margin for further simplification has been identified in several areas in relation to the information requirements, the extended Safety Data Sheets, the process to apply for authorisation and the requirements for substances in articles. Appropriate actions are set out in the following chapter.
3. Actions
3.1.Knowledge and management of chemicals throughout the supply chain
The lack of information on existing chemicals was one of the two main policy drivers triggering the development of REACH. Since the entry into force of REACH, more information on the properties and uses of chemicals (e.g. by December 2017, ECHA received 65 000 dossiers for approximately 17 000 unique registered substances) is available and being used for the assessment and management of chemical risks. In spite of this positive trend, the lack of compliant information in the registration dossiers hampers the functioning of other REACH processes and slows down the achievement of the REACH objectives for human health and environment.
The efficiency and effectiveness of the evaluation procedures, implemented by ECHA, its Committees, the Member States and the Commission, need to be improved. This will provide stronger incentives for companies to update and bring into compliance their registration dossiers as required by REACH.
Action 1: Encourage updating of registration dossiers
The Commission in collaboration with ECHA, Member States and industry will identify why registrants are not updating their dossiers and make proposals for improvements by first quarter 2019, as appropriate.
Action 2: Improve evaluation procedures
ECHA is requested to significantly increase the efficiency of the evaluation procedures by 2019 by:
(1) identifying the main reasons for non-compliance of registration dossier and developing remedies;
(2) where appropriate, applying the various evaluation procedures in parallel;
(3) systematically implementing a grouping approach 25 , where this is possible;
(4) improving work-sharing across evaluation activities with Member States; and
(5) improving decision-making procedures.
REACH extended the already existing Safety Data Sheets by adding so-called exposure scenarios. This has led to improvements in communication and more transparency in the supply chain. However, many companies, in particular SMEs, find them too technical and burdensome. In addition, the poor quality of exposure scenarios is an obstacle to providing safety information for mixtures.
Action 3: Improving the workability and quality of extended Safety Data Sheets
(1) The Commission encourages more industry sectors to develop and use harmonised formats 26 and IT tools that would provide more user-targeted information and simplify the preparation and use of extended Safety Data Sheets as well as facilitate their electronic distribution.
(2) The Commission will consider including minimum requirements for the exposure scenarios for substances and mixtures in Safety Data Sheets and request ECHA to develop a methodology for Safety Data Sheets of mixtures.
The need to better track chemicals of concern in materials and products in order to facilitate recycling and improve the uptake of secondary raw materials is discussed in the chemical product waste communication 27 , one of the deliverables of the Circular Economy Action Plan. Such tracking could also address the current difficulties for actors in the supply chain to fulfil the requirements for SVHCs in articles 28 .
Action 4: Tracking substances of concern in the supply chain
The Commission will gather evidence and assess options to address the challenges related to substances of concern, as discussed in the chemical product waste communication. The assessment will consider, among others, whether and how a tracking system could contribute to improve the workability of information requirements for SVHCs in articles.
3.2.Enhanced risk management
The slow progress of risk assessment and implementation of risk management for existing substances was another main driver triggering the development of REACH. Improved risk management measures have been introduced in companies as a result of the registration and authorisation requirements. The restriction and authorisation processes still need to be implemented more efficiently and with quicker decision making.
The implementation of the SVHC roadmap and early assessment of possible regulatory measures through a voluntary regulatory management option assessment (RMOA) is proving an effective tool to ensure that, by 2020, all known relevant SVHCs are identified, along with possible regulatory measures. The focus of SVHC identification is moving towards substances that require a case-by-case assessment of the equivalent level of concern condition 29 . The Commission, together with ECHA and Member States, will ensure that criteria for such identification are developed and applied in a consistent manner.
Moreover, the authorisation process is seen as an effective driver for substituting SVHCs along the supply chain, although efforts must be stepped up to promote substitution of SVHCs, in particular among SMEs.
Action 5: Promote substitution of SVHCs
The Commission, ECHA and Member States will step up support activities to facilitate substitution of SVHCs. Such activities may include the promotion of capacity building and collaborative networks and promoting R&D investment (EU, Member States resources) in sustainable chemicals and technology innovations.
As authorisation has become operational, a number of practical challenges and concerns have emerged that needed to be addressed. The ongoing efforts to simplify the authorisation process should continue with a view to clarifying the requirements and make the process more workable and more predictable for applicants.
When carrying out a RMOA, evidence is necessary to understand the practical workability of possible regulatory measures (authorisation or restriction) to inform the decision-making process. This includes available socio-economic information such as the known uses, number and size of actors involved in the supply chains as well as available information about technical and economic feasibility of possible safer alternative substances or technologies.
Action 6: Simplification for a more workable authorisation process
The Commission will continue to make the application for authorisation process more workable for operators, including for SMEs by:
(1) simplifying the applications for continued use of SVHCs in legacy spare parts 30 and further considering the case of low volume applications in 2018;
(2) closely monitor and address difficulties related to applications for authorisation covering multiple operators;
(3) reducing fees for applicants in joint applications for authorisation while balancing the fee levels per use in order to better reflect the workload for ECHA committees in 2018.
Action 7: Early socio-economic information for possible regulatory measures
ECHA in co-operation with the Commission and Member States will consider options to further develop and use available socio-economic information for consideration at the RMOA stage.
The number of new restrictions has so far not met the original expectations. Although the process has improved as a result of the actions initiated after the 2013 REACH review, there is room for further improvement in particular to identify relevant candidates for restriction and to increase Member State involvement.
Action 8: Improve Restriction Procedure
(1) ECHA is requested to clarify the information needed from the public consultations, including the minimum information to be submitted by industry when requesting derogations (time-limited or not) from restrictions.
(2) ECHA is requested to identify relevant cases for restriction as part of its regular screening activities, considering also substances for which only national legislation exists.
(3) The Commission will continue its efforts to identify suitable cases for restricting CMR substances in consumer articles through a simplified procedure, according to Article 68(2).
Action 9: Further enhance Member State involvement in the restriction procedure
The Commission and ECHA will work with Member States to further simplify the requirements for submitting a restriction dossier and to increase Member State capacities to develop dossiers for new restrictions and provide constructive solutions such as encouraging joint dossiers prepared by several Member States and/or in cooperation with ECHA.
Action 10: Frame the application of the precautionary principle 31
ECHA's Risk Assessment Committee and Socio-Economic Assessment Committee should ensure that their opinions indicate when scientific data do not permit a complete evaluation of risk. This should include what information is needed to address the uncertainties, the timeline for generating such information and provide an assessment of the potential consequences of inaction to enable the Commission to consider if action is warranted on the basis of the precautionary principle, underpinned in the legal text of REACH.
The interplay between authorisation and restriction is enshrined in REACH. It foresees that for substances subject to authorisation, ECHA should consider after the sunset date whether the use of such substances in articles poses risks to human health or the environment that is not adequately controlled and, if so, should start a restriction procedure. There is a need to expedite the assessment of the need for restrictions on imported articles containing substances subject to authorisation 32 in order to ensure a level playing field between economic operators in and outside the EU. It should be explored if and how applying the authorisation procedure for the non-restricted uses of SVHCs to achieve comparable risk management and substitution more efficiently and predictably.
Action 11: Interplay between authorisation and restriction
(1) ECHA is requested to consider systematically the preparation of a restriction dossier before the sunset date of each substance that is subject to authorisation and present in articles in accordance with Article 69(2).
(2) The Commission, ECHA and Member States will assess the interplay between restriction and authorisation to achieve a comparable risk reduction more efficiently through risk management and substitution.
3.3.Coherence, enforcement and SMEs
Further activities are needed to clarify the interface between REACH and other pieces of EU legislation; in particular work should continue on the interplay of REACH with occupational safety and health (OSH) legislation and with waste legislation 33 .
Action 12: Interface REACH and OSH legislation
The Commission will propose the following concrete steps to remove the overlaps and clarify the interface between REACH and OSH:
(1) How to use REACH tools (e.g. exposure scenarios, Safety Data Sheets) to enhance the effectiveness of OSH legislation.
(2) Improve the coordination of national enforcement authorities of REACH and OSH legislation.
(3) Align methodologies to establish safe levels of exposure to chemicals at the workplace by first quarter 2019.
(4) Enhance the role of ECHA's risk assessment committee (RAC), involving also social partners, to provide scientific opinions under the OSH legislation while respecting the role of the Advisory Committee on Health and Safety at Work.
Strengthening the enforcement of the obligations on all actors, including registrants, downstream users and in particular for importers, is necessary to ensure a level playing field, meet the objectives of REACH and ensure consistency with the actions envisaged to improve environmental compliance and governance 34 . Consistent reporting of Member State enforcement activities will enable a better assessment of this important aspect of REACH.
Action 13: Enhance enforcement
(1) The Commission will consider by first quarter 2019 further measures (such as recommendations, guidance documents, training and pilot projects), under the relevant legislative instrument, to clarify and enhance the role of REACH enforcement authorities as well as customs authorities in the enforcement of REACH.
(2) ECHA's Forum and Member States are requested to establish comparable parameters on enforcement. On the basis of those parameters, Member States should report annually to ECHA for the purpose of monitoring enforcement activities by Member States.
SMEs remain more vulnerable to the effects of REACH than large companies due to limited financial and human resources, especially in view of the 2018 registration deadline, where many more SMEs are expected to be involved than in previous registration deadlines as well as the challenges of downstream users.
Action 14: Support compliance by SMEs
ECHA and Member States are requested to step up efforts to develop, with input from voluntary actions by industry organisations, tailored guidance and support instruments focused on the needs of SMEs. Such instruments may include collection of best practice, generation of sector specific solutions and publication of documents in national languages.
3.4.Fees and future of ECHA
A well-functioning and efficient implementation of all REACH processes needs long term financial and resource stability so necessary competences can be maintained and efficiency gained, while taking account of budgetary constraints. ECHA's funding after 2020 needs to be considered and Member States participation to ECHA work needs to be reinforced. Over the period 2007 – 2020, ECHA funding has been coming from fees (70%) and from a balancing subsidy (30%). After 2020, the income from fees (in particular from registration) is expected to drop sharply. The sustainability of ECHA's financing therefore needs to be re-assessed.
Over the next years, it is expected that ECHA will become a European and global reference centre for the sustainable management of chemicals, capable of serving implementation of more pieces of EU legislation, should the Commission make proposals in this respect.
Action 15: Fees and the future of ECHA
(1) Bearing in mind that budgetary constraints will remain also in the post 2020 Multiannual Financial Framework, the Commission will explore ways of guaranteeing ECHA mission and independence and to assess all possible options for financing in a context of projected reduced fee income, including by containing expenditure.
(2) ECHA is invited by 2019 to:
i) reallocate staff to other areas of work following the completion of the registration process for phase-in substances to enhance the scientific and technical expertise related to the safety of chemicals as well as the evolving methodologies for their assessment;
ii) continue to identify efficiency gains and propose targets.
(3) Given the constraints identified above, the Commission will carefully assess whether to assign further tasks to ECHA and the associated resources.
3.5.Need for further assessment
The reviews related to registration requirements for low tonnage substances and polymers (Article 138) identified the necessity to assess affordability of additional registration requirements for the companies involved, especially given the number of SMEs who might be affected.
Action 16: Review of registration requirements for low tonnage substances and polymers 35
The Commission will further investigate information necessary to assess the affordability of additional information requirements for low tonnage substances or to identify relevant polymers that could be subject to registration.
The Commission will continue to monitor the impacts of the 2018 registration obligation on SMEs, looking at overall incurred costs, availability of chemical substances and possible structural changes on the EU market.
The Commission will examine various options to fill data gaps and to improve data quality, robustness and transparency in the context of REACH. This is part of a broader discussion on the EU approach on transparency, quality and independence of data 36 , 37 on which risk assessment and risk management decisions are based.
For CMR substances for which no safe exposure levels exist, there is no consensus in the EU on what level of risk could be considered as acceptable. Furthermore, the rules to establish appropriate risk management measures for such substances in REACH do not include the concept of acceptable risk. Reflections will continue on acceptable risk levels, and whether they can have a role in the relevant REACH processes.
4. Conclusions
The REACH Evaluation concludes overall that REACH is addressing today's citizens' concerns about chemical safety 38 .
REACH is effective but opportunities for further improvement, simplification and burden reduction have been identified, which can be achieved by delivering the actions outlined in the report. Those should be implemented in line with the renewed EU Industrial Policy Strategy 39 , Circular Economy Action Plan 40 and the 7th Environment Action Programme 41 .
REACH is found to be generally coherent with other EU legislation concerning chemicals and delivers the international goals as intended.
Implementation is still on-going in all areas, with some key milestones, such as the last registration deadline, still to be completed by June 2018. Many of the costs of REACH have been incurred and benefits are starting to materialise.
The REACH evaluation has concluded that the legal requirements and obligations are well tuned to achieving the needs and objectives pursued. While this communication has identified a number of actions that will further improve REACH, there is currently no need to change its enacting terms.
(1)
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136, 29.5.2007, p. 3.
(2)
OECD (2015). Preliminary analysis of policy drivers influencing decision making in chemicals management. Series on Risk Management, No. 28. Document ENV/JM/MONO(2015)21. Appendix 6 concerns REACH
(3)
100 106 substances marketed in the EU before 1981. These substances are now called phase-in substances.
(4)
Article 191(2) of the Treaty on the Functioning of the European Union (TFEU).
(5)
https://ec.europa.eu/commission/priorities/democratic-change/better-regulation_en
(6)
WSSD goal: "By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment".
(7)
See REACH Article 117
(8)
See REACH Article 138
(9)
COM(2013)49 and SWD(2013)25
(10)
SWD(2018)58
(11)
See REACH Article 138(2)
(12)
See REACH Article 138(1) and 138(3)
(13)
For further details, see SWD(2018)58
(14)
Existing substances refer to "phase in" substances in accordance with article 3 point 20 of REACH.
(15)
Further details see the SWD(2018)58
(16)
Forum for the Exchange of information on enforcement.
(17)
Roadmap on Substances of Very High Concern , February 2013.
(18)
http://ec.europa.eu/growth/sectors/chemicals/reach/special-cases_en
(19)
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
(20)
Regulation (EC) No 850/2004 on persistent organic pollutants, implementing the obligations of the Union under the Stockholm Convention.
(21)
Further details see Annex 4 of the SWD(2018)58
(22)
HBM4EU
(23)
IPCHEM
(24)
Following the last registration deadline of 2018
(25)
Assessment of groups of substances with similar properties instead of individual ones
(26)
As those developed by the Exchange Network on Exposure Scenarios (ENES)
(27)
Options to address the interface between chemical, product and waste legislation COM(2018) 32 final and SWD(2018) 20 final
(28)
Articles 7 and 33 of REACH
(29)
In accordance with Article 57(f) of REACH
(30)
Uses of SVHC to produce legacy spare parts for repairing articles no longer produced after the sunset date (e.g. aircraft and motor vehicles)
(31)
COM(2000)1 on the precautionary principle
(32)
According to Article 69(2) of REACH
(33)
Addressed by action 4 above.
(34)
COM(2018) 10 EU actions to improve environmental compliance and governance
(35)
Review according to article 138(1), 138(2) and 138(3) of REACH.
(36)
C (2017) 8414final –Communication on the European Citizens' Initiative related to glyphosate
(37)
Roadmap on Transparency and sustainability of the EU risk assessment model in the food chain
(38)
Eurobarometer survey on chemical safety