COMMISSION STAFF WORKING DOCUMENT Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions Annex 1

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Kerngegevens

Document date 08-03-2018
Publication date 09-03-2018
Reference 6916/18 ADD 2
From Secretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director
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Text

Council of the European Union Brussels, 8 March 2018 (OR. en)

6916/18 ADD 2

ENV 163 COMPET 141 IND 71 RECH 101 ECOFIN 217 ECO 22 SOC 130 SAN 77 CONSOM 59 MI 155 CHIMIE 9 ENT 41

COVER NOTE

From: Secretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director date of receipt: 5 March 2018

To: Mr Jeppe TRANHOLM-MIKKELSEN, Secretary-General of the Council of the European Union

No. Cion doc.: SWD(2018) 58 final - Part 2/7

Subject: COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

Commission General Report on the operation of REACH and review of certain elements

Conclusions and Actions

Annex 1

Delegations will find attached document SWD(2018) 58 final - Part 2/7.

Encl.: SWD(2018) 58 final - Part 2/7

EUROPEAN COMMISSION

Brussels, 5.3.2018 SWD(2018) 58 final

PART 2/7

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN

PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions

Annex 1

{COM(2018) 116 final i}

Annex 1: Procedural information

Lead DGs and internal references

The "REACH REFIT Evaluation (REACH Review 2017)" was co-led by DG Environment and DG Internal Market, Industry, Entrepreneurship and SMEs. It was included as item 2017/ENV/005 in the Agenda Planning (AP) and as Commission's REFIT Initiative item 1 in the Commission Work Programme of 2016 1 .

This initiative is linked to other actions, REFIT action 52 of the Commission Work Programme of 2015 the " Fitness Check of the most relevant chemicals legislation not covered by REACH" to be delivered in 2018, the REFIT Ex-post evaluation of the EU occupational safety and health Directives (SWD (2017) 10 final) and the new initiative item 3 of the Commission Work Programme of 2016, the Circular Economy Package with the aim to address economic and environmental concerns by maximizing efficiency in the use of resources, covering the whole value chain (including sustainable consumption, production, waste management).

Organisation and timing

An Inter-service Group to steer and provide input for the REACH report 2017 was set up in September 2015 with representatives from the Directorate Generals for Environment; Internal Market, Industry, Entrepreneurship and SMEs; Budget; Competition; Employment, Social Affairs and Inclusion; Health and Food Safety; Joint Research Centre; Justice and Consumers; Research and Innovation; Taxation and Customs Union; Trade and the Secretariat General. In addition, representatives from the European Chemical Agency (ECHA) were invited to contribute to the meetings as external experts.

The group met seven times during the evaluation process (25 September 2015, 14 April and 8 September 2016, 22 February, 29 March, 20 April and 14 June 2017).

Table 1.1 ISG meeting dates and topics of discussion as well as other consultations

Date Topics of discussion

25.09.2015 Context of the REACH report 2017;Presentation of the roadmap and planning of the work; Main elements of the roadmap; Ongoing and planned studies; the Consultation strategy

14.04.2016 Update on the roadmap; Ongoing studies with regards to the REACH report 2017; Presentation and discussion of the evaluation framework 08.09.2016 Update on the roadmap and consultation strategy; Update on work planning,

Key milestones and timelines; Questionnaires for the public consultation and the SME panel

22.02.2017 Update on recent developments and work plan; Preliminary results of the online public consultation and SME consultation; Development of the evaluation report (SWD), Outline and general sections, Section 6: Implementation state of play, Section 7: Answer to evaluation questions

29.03.2017 Update on recent developments ; Preliminary results of the online public consultation and SME consultation; Discussion on the draft evaluation report (SWD)

20.04.2017 Update and discussion on the draft evaluation report (SWD)

14.06.2017 Update and discussion on the draft evaluation report (SWD)

18.07.2017 Written consultation on the draft evaluation report (SWD) for submission to the RSB

External Expertise

The analysis underpinning this REFIT was undertaken via several thematic studies commissioned by DG Environment and DG Internal Market, Industry, Entrepreneurship and SMEs. In addition, the evaluation uses the regular reports from Member States Competent Authorities and ECHA submitted in accordance with Article 117 of the Regulation, which cover the implementation of all REACH processes and their enforcement. A description of those information sources can be found in Annex 3.

Relevant developments of the preparatory work for this REFIT evaluation were discussed at the Commission Expert Group CARACAL (Competent Authorities for REACH and CLP) 2 .

In addition, a conference was held:

  • Reporting on progress at Commission Conference "Towards phasing out animal testing"

(follow-up to the European Citizen’s Initiative).

Consultation of the Regulatory Scrutiny Board

The Regulatory Scrutiny Board (RSB) of the European Commission assessed a draft version of the present evaluation and issued its positive opinion on 29 September 2017. The Board made several recommendations to further improve the report. Those were addressed in the revised report as follows:

RSB recommendations Modification of the report

(B) Main considerations

The Board acknowledges significant efforts to collect evidence on how REACH is functioning and to report on implementation.

The Board gives a positive opinion and suggests some improvements with respect to the following key aspects:

  • (1) 
    The report does not make full use of the This recommendation has been

evidence to substantiate REACH benefits and addressed by adding relevant data

effectiveness. It does not conclude either on how

higher-than-expected costs and delays in REACH presented in the technical annexes as

processes affect effectiveness and competitiveness. well as providing a comparison of

A systematic international comparison would achievements of chemical legislation

improve the evidence base in these respects. in other jurisdictions. See sections

6.1.1 and 6.1.2 of the SWD.

  • (2) 
    The report does not identify the key findings The conclusions have been revised to

calling for action. identify issues requiring most urgent

action. See section 7 of the SWD.

  • (3) 
    The report does not sufficiently address Available evidence on enforcement

enforcement issues and their consequences for the issues has been added to the main

effectiveness of REACH for the single market

objective. body, specifically section 6.1.3 of the SWD.

  • (4) 
    The report does not sufficiently explain the Concrete steps to address overlaps

outcomes of measures already undertaken to with other legislation, in particular

address coherence of REACH with other

legislations. with OSH legislation, have been added in section 6.3.2 of the SWD.

(C) Further considerations and recommendations for improvement

  • (1) 
    Effectiveness, benefits and costs

The report contains a wealth of information on the The findings have been completed implementation of REACH and derives many of its with relevant data collected through findings on its functioning from stakeholders' views thematic studies and presented in the and opinions. These should be further corroborated technical annexes. The comparison and qualified with data extracted from the Annexes with regulatory approaches in third and supporting studies. The report should support countries has been further elaborated. the effectiveness assessment by comparing REACH The contribution of several factors to regulatory approaches in third countries. (e.g. shifting the burden of proof, When assessing effectiveness, the report explains comparison of the number of new why it is hard to evaluate the overall impacts of restrictions, non-compliance of REACH on health and the environment (e.g. long registration dossiers) to the overall latency period before benefits materialise). effectiveness of the system has been Nevertheless, the evaluation should elaborate further described, mainly in sections further on whether shifting the burden of proof to 6.1.1 and 6.1.2 of the SWD.

businesses to demonstrate the safety of chemicals The description of benefits and costs

has been more effective and efficient than has been further elaborated according continuing with pre-REACH legislation. For to this recommendation. See section instance, the report could address whether the 6.2.1 of the SWD. number of actual restrictions put in place under

REACH compared to the pre-REACH situation or to initial expectations is an indicator of the overall effectiveness of REACH. In this respect, the report should address aspects such as the value of the enhanced knowledge about chemicals or the deterrent effect of the authorisation process generated by REACH. The report should clarify the trade-offs between the incentives for firms to provide complete and accurate data vs regulators' ability to test and verify claims. It should present the current state of play.

In terms of costs, the report should address the reliability of cost estimates (e.g. not only based on business' views). It should further explain why costs were higher than expected. Some may be legitimate (e.g. forced data sharing was not considered in the original impact assessment) while others may require attention to avoid that the situation worsens (e.g. costs associated with delays generated by non-compliance, costs imposed on downstream businesses). The report should also better detail the issue of non-compliance of registration dossiers (e.g. by distinguishing between different types and seriousness of non-compliance).

It should indicate the costs in terms of foregone benefits and address how these shortcomings are dealt with.

Finally, after weighing its pros and cons, the report should transparently discuss trade-offs of the

REACH system. It could do so by comparing

REACH more systematically with other approaches

  • (2) 
    Conclusions and priorities

The report should more clearly identify key This recommendation has been findings for policymaking and clarify the urgency addressed by amending sections 4 and for action. It should explain the rationale and 7 of the SWD. methodology used to prioritise. Priorities could be laid out with a view to evaluate progress in the future. This implies hypotheses that can be tested and indicators that can deliver useful benchmarks.

  • (3) 
    Enforcement and market surveillance

Given the critical role of enforcement in the overall This recommendation has been effectiveness of the system, the report should addressed by amending section 6.1.3 elaborate on the structures, resources and of the SWD. organisation in place at Member State and EU level to ensure compliance. It should further qualify the functioning of enforcement mechanisms. It should, where relevant, assess to what extent identified flaws and limitations are affecting the effectiveness of REACH in terms of ensuring the smooth functioning of the single market.

  • (4) 
    Coherence

The report should better present the interplay of This recommendation has been

REACH with relevant EU priorities, strategies and addressed by amending section 6.3.2 legislation. It should further elaborate on the added of the SWD. value of different parallel initiatives to ensure coherence (e.g. roadmap, common understanding papers). Finally, it should explain the overarching approach undertaken to review and ensure the proper functioning of EU chemical legislation, in which the present evaluation takes place.


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Referenced document

8 Mar
'18
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions
COVER NOTE
Secretary-General of the European Commission
6916/18
 
 
 
 

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