What is REACH regulation of chemicals?

 

The REACH Regulation is the European Union's cornerstone legislation for chemical safety. It's widely considered one of the world's strictest chemical regulatory frameworks.

REACH is an acronym that stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It shifts the burden of proof onto companies, requiring them to demonstrate the safety of the substances they manufacture or place on the EU market.

The regulation officially entered into force on June 1, 2007.

🎯 The Four Pillars of REACH

The regulation's name directly reflects its four core processes, creating a lifecycle approach to chemical management.

Pillar	Description	Key Requirement
1. Registration	The foundation of REACH. Companies must register substances manufactured or imported at ≥ 1 tonne per year with the European Chemicals Agency (ECHA).	"No data, no market" principle—registration is mandatory to legally manufacture, sell, or use a substance.
2. Evaluation	ECHA and Member States assess registration dossiers and specific substances to determine if risks are adequately controlled.	ECHA checks at least 5% of dossiers. The CoRAP list identifies substances for in-depth evaluation by Member States.
3. Authorisation	Applies to Substances of Very High Concern (SVHCs). These substances cannot be used or placed on the market without a specific authorization.	SVHCs are placed on the Candidate List and eventually the Authorization List (Annex XIV). Companies must apply for authorization or phase them out.
4. Restriction	A "safety net" to restrict or ban the manufacture, use, or placing on the market of substances posing unacceptable risks.	Restricted substances are listed in Annex XVII. This can apply to any substance, not just SVHCs.

📝 Defining the Three Regulatory Objects

REACH classifies products into three distinct categories, each with different compliance obligations:

Term	Definition	Example	Typical Obligations
Substance	A single chemical element or compound	Benzene, titanium dioxide	Registration, authorization, restriction
Mixture	A combination of two or more substances (formerly "preparation")	Paints, inks, cleaning agents	Registration of substances within the mixture
Article	An object with a specific shape, design, or function	Clothing, electronics, furniture	SVHC notification and supply chain communication if articles contain >0.1% SVHC

🌍 Who Does REACH Apply To?

REACH affects a wide range of actors in the EU supply chain:

• Manufacturers: EU-based companies that produce chemical substances.

• Importers: Companies that bring chemicals, mixtures, or finished articles into the EU.

• Downstream Users: Industrial or professional users of chemicals (e.g., formulators, article producers).

• Only Representative (OR): A legal entity appointed by a non-EU manufacturer to fulfill registration obligations for them.

For non-EU companies, the regulation has a significant impact. While you cannot register a substance yourself, your products cannot enter the EU without compliance. The two main strategies are:

1. Rely on your EU Importer: Your EU-based customer registers the substance but may require detailed formulation data from you.

2. Appoint an Only Representative (OR): You hire an EU-based entity to register the substance on your behalf. This is often preferred to maintain control over your supply chain and proprietary information.

🔍 Key Definitions and Critical Concepts

• Substances of Very High Concern (SVHCs): These are chemicals with serious hazardous properties, including:

  • CMRs: Carcinogenic, Mutagenic, or toxic for Reproduction.

  • PBTs: Persistent, Bioaccumulative, and Toxic substances.

  • vPvBs: very Persistent and very Bioaccumulative substances.

  • Substances of "equivalent concern" (e.g., endocrine disruptors).

• The 0.1% Threshold: If your article (e.g., a phone case, a chair) contains an SVHC on the Candidate List at a concentration above 0.1% weight by weight (w/w), you have specific legal duties:

  1. You must provide sufficient information to your customers to ensure safe use.

  2. You must respond to consumer requests for information within 45 days.

  3. You must submit a SCIP notification to ECHA (since 2021).

🆕 Recent Developments and Updates

• PFAS Restrictions: In late 2024, the European Commission restricted the use of undecafluorohexanoic acid (PFHxA), a type of PFAS "forever chemical." The ban covers food packaging, cosmetics, and textiles, with rules starting to apply from October 10, 2026.

• Ongoing Evolution: REACH is currently undergoing review by the European Commission to ensure its continued effectiveness and alignment with the EU's Green Deal and Zero Pollution goals.

⚠️ Consequences of Non-Compliance

Failure to comply with REACH can have severe consequences:

• Market Access Denied: Products cannot be placed on the EU market.

• Criminal Penalties: Infringements can lead to imprisonment (up to 5 years) and significant fines.

• Supply Chain Disruption: EU importers will refuse products that do not have the necessary registrations or contain restricted substances.