Chemical Regulation Compliance (REACH Compliance) Certification

REACH (Regulation (EC) 1907/2006) is a horizontal regulation governing the registration, evaluation, authorisation and restriction of chemicals in the EU. It is not within CE-mark scope but affects almost every product. For manufacturers and importers of articles, the most critical obligations are: communicating information when a substance of very high concern (SVHC) in the article exceeds 0.1% by weight, notification to the SCIP database, and compliance with Annex XVII restrictions.

• All manufacturers exporting articles to the EU
• Manufacturers of textiles, toys, electronics and furniture
• Importers of chemical substances and mixtures
• Firms collecting substance declarations in the supply chain

Mandatory for products placed on the EU market. The type of obligation varies by role: a substance manufacturer/importer registers; an article manufacturer/importer is obliged with SVHC notification, SCIP notification and compliance with Annex XVII restrictions. Non-EU manufacturers can take on the registration obligation by appointing an EU-based Only Representative.

• Determining the role: substance manufacturer/importer, downstream user, article manufacturer/importer
• Substance registration and obligations by tonnage band
• Monitoring the SVHC candidate list (updated regularly)
• Assessing SVHC content in the article against the 0.1% threshold
• Communicating information down the supply chain and notification obligations to ECHA
• Notification to the SCIP database
• The Annex XIV authorisation list and Annex XVII restrictions
• Preparing and updating the safety data sheet (SDS)

1. 1Application and Product DescriptionThe product family, model list, technical specifications and target market are determined. The applicable standard and certification route become clear at this step.
2. 2Technical File ReviewDesign documents, the bill of materials, critical-component certificates and the instructions for use are examined.
3. 3Product TestingThe tests the relevant standard requires are carried out. The test report is the fundamental basis for the certification decision.
4. 4Factory AuditIf the scheme requires it, the continuity of manufacturing and factory production control (FPC) are verified on site.
5. 5Issuing the Certificate and MarkingOnce conformity is verified, the certificate is issued; the marking rules for the product and packaging are applied.
6. 6Follow-up AuditsDepending on the scheme, periodic factory audits and/or follow-up testing on samples taken from the market are carried out.

The validity period varies by scheme: some product certificates are indefinite and rely on periodic factory audits, while some schemes (e.g. country market marks) require annual or per-shipment renewal. Every design change to the product requires the certificate to be reviewed.

• The list of product models and variants
• Technical drawings, diagrams and the bill of materials
• Certificates for critical components
• The instructions for use and a sample label
• Existing test reports, if any
• Production-site details

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of models and variants in the product family
• The test scope the applicable standard requires
• Whether a factory audit is required
• The number of target markets and whether each requires separate testing
• Whether existing test reports can be accepted

Product certification is carried out under ISO/IEC 17065; The tests that form the basis for certification are carried out in laboratories with ISO/IEC 17025 accreditation. The two scopes are separate. Recognition between accreditation bodies is provided through IAF and ILAC agreements.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• RoHS ComplianceHazardous Substance Restriction Compliance
• CEEU Product Conformity
• UKCAUnited Kingdom Conformity
• ENECElectrical Product Safety
• GSGermany Product Safety
• S-MarkProduct Safety Mark
• ULNorth America Product Safety
• ETLNorth America Product Safety