REACH shifts the responsibility from public authorities to industry with regards to assessing and managing the risks posed by chemicals and providing appropriate safety information for their users.
It impacts on a wide range of companies across many sectors beyond the chemical industry. It requires new forms of cooperation among companies, enhancing communication along the supply chain, as well as developing tools to guide and assist companies and public authorities in its implementation.
Objectives of REACH
The main aims of REACH are to ensure a high level of protection for human health and the environment, including the promotion of alternative test methods, as well as the free circulation of substances on the internal market and the enhancement of competitiveness and innovation.
The European Commission plays a key role in implementing REACH legislation and in taking decisions on a number of REACH processes.
In particular, the Commission plays a key role in the authorisation process as it determines the substances subject to authorisation and decides whether to grant authorisation. It also adopts EU wide restrictions. In recent years, the Commission has reviewed a number of REACH Annexes (186 KB).
The Commission has prepared implementing legislation, which is necessary to implement provisions of REACH such as:
- regulation on fees, which sets fees to be paid by industry for registration and applications for authorisation
- regulations on the arrangements for the Board of Appeal of the European Chemicals Agency
- regulation on test methods.
In these tasks, the Commission is supported by a regulatory Committee composed of representatives from all EU countries.
REACH implementation issues are discussed by the Expert Group of Competent Authorities for REACH and CLP (CARACAL).
The Commission provides advice on key issues related to the interpretation of REACH and supports the European Chemicals Agency (ECHA) in its tasks, including drafting guidance documents and helpdesk questions for ECHA and the REACH helpdesk network.
The Commission has representatives in the Management Board of ECHA and may participate in meetings of the Committees of the Agency.
The Commission works closely with the European Chemicals Agency (ECHA) and national authorities in the implementation of the REACH regulation.
Read more about the key players.
REACH is based on the principle of ‘no data, no market’.
This means that all manufacturers and importers of chemicals must identify and manage risks linked to the substances they produce and market. For substances manufactured or imported in quantities of one tonne or more per year, per company, this must be demonstrated in a registration dossier submitted to the European Chemicals Agency (ECHA).
This obligation applies to substances on their own and in mixtures. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, and electronic chips). However, certain substances are exempted from registration under REACH (see ECHA/Guidance on registration – Chapter 2.2.2).
Without registration, substances cannot be manufactured or imported into the EU.
More information is available on ECHA’s website on registration
The European Chemicals Agency (ECHA) may check that registration dossiers comply with the Regulation.
It must also evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals, and that adequate information is provided.
Authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
More information on the evaluation of chemicals (ECHA)
REACH includes an authorisation requirement to ensure that the risks from substances of very high concern (SVHCs) are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies.
Substances subject to authorisation are listed in Annex XIV to the REACH Regulation. Once included in this Annex, a substance cannot be placed on the market for use or used after a given date (the so-called 'sunset date') unless the companies concerned are granted an authorisation for the specific use(s).
Authorisations are granted by the Commission, after obtaining the opinion of the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) of the European Chemicals Agency (ECHA).
An authorisation may be granted if either the risks from the use of the substance are adequately controlled or the socio-economic benefits outweigh the risks to human health or the environment.
More information on authorisation and the list of authorisation decisions
EU countries or the European Commission (via ECHA) may propose EU-wide restrictions
on the manufacture, use, or placing on the market of substances causing an unacceptable risk to human health or the environment.
Restrictions are designed to manage unacceptable risks that are not addressed by the other REACH processes or by other EU legislation. Restrictions are listed in Annex XVII to the REACH Regulation.
Enforcement of REACH is a responsibility of national authorities, through official controls and ensuring penalties in case of non-compliance.
The coordination of enforcement activities and exchange of information is possible through the Forum for Exchange of Information on Enforcement (the Forum), set up byECHA.
More information on enforcement
REACH requires that companies pay for certain services delivered by the European Chemicals Agency (ECHA). This includes
- registration of chemicals
- requests (in a registration submission) that certain information is kept confidential
- certain updates of registration submissions
- notifications to ECHA of product and process orientated research and development activities, with a view to obtaining an exemption from registering; and all related extensions to this exemption
- applications for authorisation for chemicals included in Annex XIV of REACH and reviews of authorisations
- appeals to the board of appeal of the agency
Guidance
A number of guidance documents can be found on the ECHA website. They aim to support industry and authorities in fulfilling their obligations under REACH and to assist in its implementation.
Helpdesk
EU Countries have established national helpdesks to assist industry in understanding its role and obligations under REACH.
The ECHA helpdesk also provides support to all companies registering substances.
In addition, there is a helpdesk on using IUCLID5, the software tool through which companies are required to submit their registrations under REACH.
For more information, including the contact details of national helpdesks, please consult the ECHA helpdesks page.
The REACH regulation requires that the Commission regularly reports on progress in the achievement of the regulation's objectives.
Second REACH review (REACH REFIT Evaluation)
The Commission published the second review of REACH on 5 March 2018, which includes a Commission report on the operation of REACH and a comprehensive evaluation report. The evaluation was conducted under the Commission’s REFIT programme.
The REACH Review (REACH REFIT Evaluation) built on the findings of the first REACH Review (2013) and has examined key developments since then.
Roadmap
The REACH REFIT evaluation (REACH review 2017), was carried out in line with the principles of better regulation and covered the five compulsory evaluation criteria: effectiveness, efficiency, relevance, coherence and EU added value.
The roadmap described in detail how the REACH REFIT evaluation (REACH Review 2017) has been carried out.
Evidence gathering
As a basis for its evaluation, the Commission drew on a broad range of information sources, including reports from EU Member States and ECHA as well as thematic studies tendered by the Commission and carried out by external consultants.
Stakeholder consultation is another important source of evidence, data and information linked to the implementation of REACH.
Stakeholder consultation
Stakeholder consultation was an important element of the REACH REFIT evaluation (REACH Review 2017). The consultation strategy provides additional details about the consultation objectives, activities and tools that were planned.
A public consultation was carried out to obtain stakeholders' views on the approach to the evaluation and collect any potentially missing elements. The online public consultation ran from 28 October 2016 until 28 January 2017. You can access the online publication results below.
Furthermore, a specific consultation on SME relevant issues was carried out through the Europe Enterprise Network (EEN).
Online publication results
| Contribution published under the name provided | Contribution published anonymously | Contribution not to be published | TOTAL | |
| Registered organisations* | 154 View responses - Xls file 1 with businesses and industry associations - Xls file 2 with NGOs, consumer, trade unions academia and others
View position papers - Zip file 1 with businesses (registered) - Zip file 2 with industry associations (registered) - Zip file 3 with others (registered) | 28 View responses View position papers
| 10 | 192 |
| Public authorities or inter-governmental organisations | 19 View responses Position papers
| 6 View responses No position papers | 1 | 26 |
| Unregistered organisations and citizens | 83 View responses Position papers | 116 View responses Position papers | 38 | 237 |
| Total | 256 | 150 | 49 | 455 |
Studies
The evidence for REACH REFIT was gathered from a large number of studies and reports.
The bigger picture and links with other on-going Commission initiatives
This evaluation took place in parallel with the fitness check on the most relevant chemicals legislation (excluding REACH - except for the PBT/vPvB criteria), as well as related aspects of legislation applied to downstream industries and was carried out in full coordination. There has been also an ex-post evaluation of 24 EU directives in the area of health and safety at work.
Evaluation by the European Chemicals Agency
The final report of the evaluation of the European Chemicals Agency (ECHA) and its annexes were commissioned by the Directorate General Internal Market, Industry, Entrepreneurship and SMEs. This evaluation study was performed by Deloitte and VVA.
The study is one of other studies carried out in the framework of REACH REFIT evaluation.
Objective and scope of the study
The objective was to evaluate the performance of the European Chemicals Agency (ECHA) following the publication of the better regulation guidelines.
The scope of the evaluation covers the full range of ECHA’s operations and processes under the REACH, CLP, BPR and PIC Regulations. This evaluation is based on the assessment of the effectiveness, efficiency, coherence, relevance and EU added value of ECHA’s work.
Approach used
The evaluation of ECHA was based on a comprehensive analytical framework. It comprised the evaluation questions and their respective judgement criteria, indicators and information sources.
The data collection tools used to gather the relevant information consisted of
- document review
- stakeholder interviews
- an online company survey
- a comparative analysis with similar EU Agencies
- a targeted process analytics exercise
REACH Review 2013
In 2013, the Commission published its first review of REACH. This was a broad assessment of the first five years of REACH, paying special attention to the impact on small and medium-sized enterprises (SMEs).
In its review, the Commission concluded that no major overhaul of the legislation was required before the last registration deadline of 2018.
Other chemical legislation
For more information on other chemical legislation, see our dedicated page.