Navigating EU chemical regulations can be challenging, but compliance is essential to avoid legal risks and ensure product safety. The three primary regulations — REACH, POP, and CLP — govern the registration, classification, and restriction of chemicals in the EU. This guide simplifies your obligations under each regulation for manufacturers, importers, and distributors.

REACH applies to three main categories:

• Substances – Individual chemical elements or compounds.
• Mixtures – Combinations of two or more substances (e.g., paints, detergents).
• Articles – Objects with a specific shape, surface, or design that determines their function (e.g., clothing, electronic devices).

An article is an object whose function is primarily determined by its shape, surface, or design rather than its chemical composition.

• If an object’s function mainly depends on its form, shape, or design, it is considered an article under REACH.
• Unlike substances or mixtures, articles do not require REACH registration unless they contain restricted substances.
• Articles do not require a Safety Data Sheet (SDS), CLP labeling, or Poison Center Notification (PCN).

• Clothing and accessories
• Electronic devices
• Toys (e.g., stuffed animals)
• Thermometers (excluding mercury-containing ones)
• Batteries

For EU Operators in the supply chain (manufacturers, importers, distributors, and other suppliers):

• Information duty: If an article contains more than 0.1% of a Substance of Very High Concern (SVHC), suppliers must:
  • Inform B2B recipients within one day of the SVHC being added to the list.
  • Inform consumers within 45 days of a request regarding the presence of SVHCs.
• Restrictions (Annex XVII): Some substances are prohibited or restricted in articles.

Additional obligations for importers:

• Notification to ECHA: If an article contains more than 1,000 kg/year of an SVHC, importers must notify the European Chemicals Agency (ECHA), unless the substance is already registered for that use.
• SCIP Notification (waste framework directive): Required if the article contains more than 0.1% SVHC.

• Ensure manufacturers understand and comply with REACH.
• Verify SDS availability and compliance with REACH, CLP, and POP.
• Check that restricted and SVHC substances are not present.

The POP Regulation (EU) 2019/1021 controls the production, sale, and use of persistent organic pollutants (POPs) —  chemicals that remain in the environment for long periods and pose health risks.

• POP regulation: Focuses on global environmental risks and prohibits or restricts persistent, bioaccumulative, and toxic substances.
• REACH Annex XVII: Regulates hazardous substances based on their specific risks during use.

• Electronics: Flame retardants in plastic casings and circuit boards.
• Furniture & textiles: Fire-resistant coatings on upholstery, carpets, and curtains.
• Building materials: Insulation foams containing POPs.
• Industrial chemicals & pesticides: PFOS in metal plating, banned pesticides like DDT.
• Automotive & aviation: Hydraulic fluids with POPs.
• Food packaging: Non-stick coatings containing POPs.

• Prohibited from producing substances listed in POP Annex I.
• Must verify raw material compliance.

• Ensure that products do not contain restricted POPs before entering the EU market.

• Ensure compliance and verify that no restricted substances are present.

The CLP Regulation (EU) 1272/2008 ensures that chemical hazards are clearly communicated to workers and consumers through standardized classification and labeling.

• Classification: Identify if a substance or mixture is hazardous.
• Labelling: Include correct hazard pictograms, signal words, hazard statements, and precautionary statements.
• Packaging: Ensure safe containment to prevent leaks or unintended exposure.
• SDS Compliance: Provide SDS in accordance with REACH Annex II.
• PCN Notification: Report hazardous mixtures (excluding those with only H200-H205, H280-H281, H400, H410-H413) to Poison Centers.

• ECHA Notification: Classify and label hazardous substances before placing them on the market.

• Verify compliance with CLP labeling and packaging rules (e.g., tactile warnings, child-resistant fastenings).

• Candles (due to fragrances)
• Markers and pens (due to solvents)
• Cleaning products and detergents
• Adhesives and glues
• Paints and coatings

Under the General Product Safety Regulation (GPSR) (EU) 2023/988, consumer products require an economic operator (e.g., an authorised representative) within the EU to ensure compliance and product safety (see Annex C). While REACH (EU) 2019/1020 references market surveillance, Article 4 — which mandates an economic operator in the EU — does not apply to REACH. However, with the introduction of GPSR, this requirement now extends to consumer products, whereas substances intended solely for professional use may not fall under this obligation.

One of our key responsibilities as an authorised representative is to ensure that products placed on the market are not dangerous. This includes verifying compliance with:

• Substance restrictions under REACH and POP regulations
• Labelling requirements under CLP

While some of these regulations include registration obligations, we do not handle these registrations directly. Instead, we ensure that manufacturers are fully aware of their obligations.

A common question is whether substances and mixtures (as defined under REACH) qualify as products. Annex A of this document explores this in detail, confirming that substances and mixtures can be considered products. If they are consumer products, they must have an economic operator in the EU.

Neither non-EU manufacturers nor authorised representatives are responsible for REACH and CLP registration obligations. The importer holds this responsibility entirely (see Annex B).

We can represent substances and mixtures under specific conditions. Additionally, articles (as defined in REACH) are treated like any other product, and we can also represent them (see Annex A).

Need expert guidance on ensuring compliance? Contact us today to discuss how we can help you navigate EU chemical regulations efficiently!

We can support your business in navigating REACH, POP, and CLP regulations efficiently. Contact us today to discuss your regulatory needs and ensure compliance with EU chemical laws.