How do ECHA and REACH make chemical substances safer?

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The European Union wants chemicals to be manufactured, used and disposed of safely. The core instrument of this policy is the REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals). The European Chemicals Agency (ECHA), based in Helsinki, plays a central role in this. Without ECHA, REACH would be very difficult to implement in practice.

What is REACH?

REACH has been the most important piece of European legislation on chemical substances since 2007. It pursues three main objectives:

• protecting human health and the environment from the risks posed by chemicals;
• promoting innovation and the competitiveness of the European chemical industry;
• increasing transparency about which substances are used and what risks are associated with them.

REACH does not apply only to manufacturers of chemicals: importers, distributors and many downstream users (e.g. manufacturers of paints, plastics, electronics or cosmetics) are also affected.

What is ECHA?

• ECHA manages the registration of substances (databases, IT systems, dossier evaluation).
• ECHA coordinates – together with the Member States – the evaluation of substances and dossiers.
• ECHA develops proposals and opinions on authorisations and restrictions (limitations/bans).
• ECHA supports companies and national authorities with guidance, helpdesks and information services.

ECHA’s core activities under REACH

1. Registration of chemical substances
Companies that manufacture or import one tonne or more of a chemical substance per year in the EU must register it with ECHA. The Agency:

• manages the central REACH database with registration dossiers;
• checks the completeness of the dossiers (including information on properties, use and exposure);
• supports companies with guidance documents, IT tools (e.g. REACH‑IT) and helpdesks.

Without a valid registration, a substance may in principle not be placed on the EU market: “no data, no market”.
 

2. Evaluation of substances and dossiers
ECHA examines whether the information submitted is sufficient and scientifically robust. This takes place at two levels:

• Dossier validation and evaluation: ECHA checks, on a targeted or random basis, whether testing strategies and risk assessments are consistent and may request additional data.
• Substance evaluation: together with the Member States, ECHA identifies substances that give rise to concern (e.g. due to widespread exposure or hazardous properties) and initiates an in‑depth examination.

This process helps to identify knowledge gaps and take targeted measures where they are most urgently needed.
 

3. Authorisation of substances of very high concern (SVHC)
Some substances are identified as substances of very high concern (SVHC), for example because they:

• are carcinogenic, mutagenic or toxic for reproduction (CMR);
• are persistent, bioaccumulative and toxic (PBT or vPvB);
• have similarly serious effects, such as harmful hormonal (endocrine‑disrupting) properties.

ECHA:

• proposes which substances should be placed on the Candidate List and subsequently on the Authorisation List (Annex XIV);
• assesses applications for authorisation from companies that wish to continue using an SVHC;
• advises the European Commission on whether to grant or refuse an authorisation, often with time limits and conditions attached.

The aim is to gradually reduce the use of these substances and – where possible – replace them with safer alternatives (substitution).
 

4. Restrictions and bans
Some risks require general restrictions or bans throughout the EU, for example for:

• lead in consumer products;
• certain plasticisers (phthalates) in toys;
• PFAS in specific applications.

ECHA:

• identifies, together with the Member States, risks that are not adequately controlled;
• prepares restriction dossiers with a scientific justification;
• advises the European Commission, which then decides on inclusion in Annex XVII to REACH (restrictions).

Restrictions are an effective tool to phase out or severely limit harmful uses.
 

5. Risk communication and transparency
ECHA operates a public database containing information on thousands of registered substances, including:

• hazards (e.g. classification and labelling);
• registered uses;
• recommended protective and safety measures.

This increases transparency in the supply chain and helps companies, authorities, NGOs and citizens to make better‑informed decisions.
 

6. Cooperation with stakeholders
ECHA works closely with:

• industry: through registrants’ fora, guidance documents and helpdesks;
• scientists and experts: in scientific committees such as the Committee for Risk Assessment (RAC) and the Committee for Socio‑Economic Analysis (SEAC);
• NGOs and the public: through consultations on authorisations and restrictions as well as public hearings.

Thanks to this broad involvement, regulation is better grounded scientifically and more widely accepted by society.
 

7. Reduction of animal testing
REACH requires extensive toxicity data, but ECHA explicitly promotes:

• the use of alternative testing methods, such as in‑vitro tests and (Q)SAR models;
• data sharing between companies to avoid duplicate animal tests;
• “read‑across” approaches, where information from similar substances is used.

In this way, both the number of animal tests and costs for companies are reduced, without compromising safety.
 

8 Practical implications for companies
For companies, REACH and ECHA’s role mean, among other things:

• obligations regarding registration, communication in the supply chain and frequent updates of safety data sheets;
• the need for risk‑management measures in the workplace and for customers;
• strategic decisions on the product portfolio: continue to rely on substances of concern or invest in safer alternatives?

Companies that cooperate with ECHA at an early stage and follow the guidance often benefit from:

• better compliance and a lower risk of fines or market restrictions;
• a stronger reputation with customers and regulators;
• more control over their substance management and future regulatory developments.

Benefits of ECHA’s role at a glance

• improved protection of human health and the environment through systematic risk assessment;
• greater transparency on chemicals on the European market;
• a level playing field for companies within the EU through harmonised rules;
• incentives for innovation, as hazardous substances must be replaced by safer alternatives.

Frequently asked questions about ECHA and REACH

• What role does ECHA play in the authorisation of hazardous substances?
  ECHA assesses authorisation applications, collects scientific evidence, conducts public consultations and advises the European Commission on whether the use of a substance of concern should continue to be authorised.
• How does ECHA cooperate with stakeholders?
  Through scientific committees, consultations, working groups, webinars, guidance documents and helpdesks, ECHA involves industry, science, NGOs and citizens in decision‑making processes.
• Why is ECHA’s role in REACH so important for the EU?
  ECHA ensures that REACH’s ambitious objectives – protecting human health and the environment and ensuring a well‑functioning internal market – are translated into practical, enforceable rules.
• How does ECHA prevent unnecessary animal testing?
  By promoting and, where possible, requiring alternative test methods and data sharing, as well as critically assessing proposals for new animal tests.
• What role does ECHA play in transparency?
  ECHA publishes extensive information on registered substances, their risks and restrictions in a publicly accessible database, enabling anyone interested to consult it.
• How can companies work with ECHA to comply with REACH?
  Companies can use ECHA’s IT tools, guidance documents, helpdesks and webinars, and participate in consultations and registrants’ fora.
• What are the consequences of non‑compliance with REACH?
  Monitoring and enforcement are the responsibility of the Member States, but infringements can lead to fines, sales bans, product recalls and significant reputational damage.

Conclusion

ECHA is the central hub of the REACH legislation. Through the coordinated registration, evaluation, authorisation and restriction of chemicals, the Agency helps to make the European market safer and more transparent. This is not only crucial for the health of people and the environment, but also provides companies with clarity, structure and opportunities for sustainable innovation.

Also read: The development of bio-based chemicals in corporate managementy

Reservation
This information has been compiled with the greatest possible care, in some cases from different information sources. (Interpretation) errors are not excluded. No legal obligation can therefore be derived from this text. Everyone dealing with this subject has the responsibility to delve into the matter!