Definition and legal framework of REACH
REACH is the abbreviation for the ‘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.’ The REACH Regulation constitutes the fundamental European chemicals legislation and has regulated the safe manufacture, placing on the market, and use of chemical substances in the European Union and the European Economic Area since 1 June 2007. The aim of REACH is to ensure a high level of protection for human health and the environment, as well as to guarantee the free trade of substances within the internal market.
Scope of the REACH Regulation
The scope of REACH generally covers all chemical substances, both as individual substances and in mixtures and articles. REACH applies to manufacturers, importers, distributors, and downstream users in the EU. Certain substances and product groups are excluded from the scope, such as radioactive substances, waste, and some pharmaceuticals and biocidal products, provided they are already regulated under other specific legislation.
Substances, Mixtures, and Articles
- Substance: A chemical element and its compounds in natural form or as obtained by a manufacturing process.
- Mixtures: Mixtures or solutions consisting of two or more substances.
- Articles: Objects to which a special shape, surface, or design is given during production.
Fundamental obligations under REACH
Registration obligation
A central pillar of the REACH Regulation is the registration obligation for manufacturers and importers of substances produced or imported in quantities of more than one tonne per year. The substances must be registered with the European Chemicals Agency (ECHA). Registration requires the submission of extensive data on the properties, uses, and risks of the substances.
Actors required to register
- Manufacturers: Any natural or legal person established in the EU who manufactures substances.
- Importers: Any natural or legal person established in the EU who imports substances from non-EU countries.
Information and documentation obligations
Manufacturers, importers, and distributors must pass on information about substances along the supply chain to ensure safe use. This includes safety data sheets, exposure scenarios, and risk management measures.
Evaluation
Evaluation takes place at two levels:
- Dossier evaluation: Examination of the completeness and quality of the registration dossiers by ECHA.
- Substance evaluation: Assessment of substances suspected of having serious effects on health or the environment, carried out by the competent national authorities.
Authorisation obligation
For substances of very high concern (SVHC), authorisation is required. These substances may only be used after prior EU-wide authorisation. The aim is the gradual substitution of these hazardous substances with less hazardous alternatives.
Restriction
Certain hazardous substances, mixtures, or articles may be subject to restrictions under Annex XVII of the REACH Regulation. These restrictions may prohibit or limit manufacture, placing on the market, or specific uses.
Governance and responsibilities under REACH
European Chemicals Agency (ECHA)
ECHA is the central authority for implementing the REACH Regulation. It is responsible for receiving, evaluating, and publishing registration dossiers, as well as for the scientific evaluation of substances and the development of restriction and authorisation proposals.
National enforcement authorities
Monitoring and enforcing the requirements of the REACH Regulation are the responsibility of the competent authorities of the EU Member States. These authorities carry out inspections, penalise violations, and, if necessary, impose national measures.
Special legal aspects of REACH
Principle of ‘No data, no market’
Without proper registration, a substance may not be placed on the market or used. This is known as the principle of ‘No data, no market’ and constitutes a central requirement of the Regulation.
Data sharing and consortia
REACH requires joint use of data (data sharing) to avoid duplication of work and minimise animal testing. Companies registering the same substance are required to cooperate and may form consortia for this purpose.
Relationship to other legal acts
The REACH Regulation is designed as a so-called horizontal regulation and takes precedence over sectoral regulations (e.g. Cosmetics Regulation, plant protection law) only to the extent that they do not already provide comprehensive rules for certain risks.
Sanctions and legal consequences of violations
Violations of the obligations under REACH, such as failure to register, disregard of restrictions, or inadequate communication of information, constitute administrative offences or criminal acts. Specific sanctions are regulated nationally and may include fines as well as official orders for recall or destruction of substances.
Significance and impact of REACH
REACH has far-reaching consequences for manufacturers and users of chemicals in Europe. The Regulation promotes the development of safer alternatives, increases transparency, and improves information exchange along the supply chain. REACH also applies to companies outside the EU whose products are to enter the European market, as they must fulfil obligations via a so-called ‘Only Representative.’
Literature and further information
- REACH text version: Regulation (EC) No 1907/2006
- European Chemicals Agency (ECHA): www.echa.europa.eu
- Federal Institute for Occupational Safety and Health (BAuA): www.baua.de
REACH is one of the most comprehensive chemical regulatory frameworks worldwide. Through mandatory registration, evaluation, authorisation, and restriction, manufacturers, importers, and other market participants are required to make an active contribution to safe chemical policy within the EU and beyond.
Frequently Asked Questions
Must a company register its substances under REACH, even if they are imported?
As soon as a company imports chemical substances as such, in mixtures, or in articles from countries outside the EU, there is generally a registration obligation under REACH Regulation (EC) No 1907/2006. This means that importers must carry out full registration for every substance they place on the EU market in quantities of at least one tonne per year. Extensive information on the hazards, uses, and safe handling of each substance must be provided. However, there are some exceptions, such as for certain polymers, waste, intermediates (under certain conditions), substances that have already been registered for the same uses, substances with specific exemptions under Annexes IV and V of the REACH Regulation, and substances that are already regulated by other EU legislation. It is especially important to note that companies based outside the EU cannot fulfil their obligations themselves, but must appoint a so-called ‘Only Representative’ to comply with legal requirements.
What information obligations exist for downstream actors (downstream users) under REACH?
Downstream users who use substances as part of their industrial or commercial activities are subject to numerous legal obligations. They must ensure that their uses are covered by the registrations of their upstream suppliers and are listed in the safety data sheet. If a use is not covered, they can either forward additional information about the use to their supplier so that the registration can be updated, or submit their own ‘Downstream User Chemical Safety Report.’ There are also obligations to pass on information in the supply chain, especially when new information on hazardous properties or safe uses of substances becomes known. The downstream user is also required to respond to official information requests and to ensure their own compliance with REACH requirements, including implementation of the risk management measures recommended in the safety data sheet.
How can companies determine whether their products are subject to restrictions or authorisation requirements under REACH?
Companies are legally obliged to regularly check whether the substances they manufacture, import or place on the market are listed in Annex XIV (authorisation-required substances) or XVII (restrictions) of the REACH Regulation. Inclusion of a substance in Annex XIV means that its use, regardless of quantity, requires prior authorisation from the European Chemicals Agency (ECHA), unless specific exemptions apply. Annex XVII lists use restrictions for certain substances or mixtures which may only be sold or used under specified conditions or may even be completely prohibited. Companies must therefore systematically verify whether their products fall under these annexes, monitor updates to the lists, and ensure practical implementation through adaptation of formulations, safety data sheets, labelling, or product withdrawals. Failure to comply may lead to sales bans and legal sanctions.
What are the legal consequences of breaches of REACH provisions?
Breaches of REACH provisions constitute administrative offences or even criminal acts, depending on the severity of the breach and national implementation laws. Sanctions may include substantial fines, sales bans for the affected substances or products, recall and take-back obligations, and criminal charges. The nationally competent authorities (such as in Germany the Federal Institute for Occupational Safety and Health, BAuA) are empowered to monitor and enforce the provisions. Particularly serious breaches include failing to register substances before placing them on the market, failing to comply with restrictions, or failing to provide required safety data sheets. In addition to immediate legal consequences, there may also be civil liability risks and reputational damage.
What documentation and record-keeping obligations exist under REACH?
Companies are required to retain all information relating to the manufacture, import, use, and communication of substances for at least ten years after the last manufacture, import, supply, or use. This documentation obligation includes, among other things, registration documents, safety data sheets, decision-making bases for substances used, communication within the supply chain, and evidence of risk and hazard assessments. Compliance with this retention obligation is essential for demonstrating compliance to authorities during inspections or audits and for possible queries from downstream users. The documents must be at all times legible, traceable, and immediately accessible to the competent authorities upon request.
What role does the Safety Data Sheet (SDS) play under REACH, and what legal requirements apply to it?
The Safety Data Sheet (SDS) is the central tool for information transfer along the supply chain under Article 31 of the REACH Regulation. It serves to inform commercial users about the properties of hazardous substances and mixtures, and necessary measures for safe handling. Legal requirements include mandatory delivery of the SDS in the recipient’s national language and compliance with the EU-wide harmonised structure set out in Annex II of the REACH Regulation. Companies are required to update the SDS as soon as new information on hazards, uses, or risk management measures becomes available. Incorrect, incomplete, or outdated safety data sheets can lead to both regulatory and liability consequences. Correct implementation of this obligation is therefore an essential part of REACH compliance.
What should be considered when communicating about substances of very high concern (SVHC) in articles?
Article suppliers are required under Article 33 of REACH to proactively inform their customers if their product contains a substance of very high concern (SVHC) that is on the candidate list, at concentrations above 0.1% by weight. This information obligation applies regardless of quantity and regardless of whether a safety data sheet is provided. At a minimum, they must provide the name of the SVHC and sufficient information for safe use. In addition, suppliers are required to provide information on contained SVHC to consumers, free of charge, within 45 days of a request. Companies must therefore establish processes for monitoring the candidate list and reliable communication both along the supply chain and towards end users, as non-compliance may also result in official sanctions and sales bans.
