Entering the EU Market: Chemicals Legislation (REACH)

REACH is a horizontal regulation governing the registration, evaluation, authorisation and restriction of chemicals in the EU. It is not within the scope of the CE marking but affects almost all products.

The obligation varies by role: the manufacturer or importer of a substance registers it; the producer and importer of an article are obliged to make SVHC notification, SCIP notification and to comply with the Annex XVII restrictions. A manufacturer outside the EU can take on the registration obligation by appointing an Only Representative established in the EU.

• An inventory of product components and materials
• Supplier substance declarations
• SVHC content assessment and analysis reports
• The SCIP notification record
• The safety data sheet (for substances and mixtures)
• The Only Representative agreement (where appointed)

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• The SVHC candidate list is updated regularly and must be monitored
• The 0.1% threshold is calculated not over the whole product but over each article
• REACH is not within the scope of CE but CE-marked products are subject to it as well
• Appointing an Only Representative is not mandatory but reduces the burden on customers

1. 01REACH and RoHSRoHS limits certain substances in electrical products by a homogeneous material threshold; REACH extends to all products and creates registration, authorisation, restriction and information duties.
2. 02REACH and the CLP classification arrangementCLP governs the classification, labelling and packaging of substances and mixtures; REACH is a registration and restriction arrangement. The safety data sheet stands at the intersection of the two.
3. 03REACH and POPs legislationPersistent organic pollutants are prohibited by separate legislation; the REACH restriction list does not cover them and the two lists are checked separately.
4. 04REACH and other markets' chemical arrangementsMany markets have established similar registration arrangements, but the lists, thresholds and tonnage rules differ; an EU registration is not valid in another market.

This page describes entry into the European Union market. The scheme itself — its scope, process, validity period and required documents — is covered in detail on the certification page.