Huak's REACH Certification & Testing Services

1. SVHC Candidate List (Substances of Very High Concern) includes substances posing serious irreversible risks to human health and the environment (e.g., CMR, PBT, vPvB). Enterprises are obligated to supply chain communication and SCIP notification. Notification to ECHA is required if the substance concentration exceeds 0.1% and the annual tonnage exceeds 1 tonne. Substances on this list may later be moved to the Authorisation List.

2. Authorisation List (Annex XIV) is a control list for substances of extremely high risk, selected from the SVHC Candidate List. It includes sunset dates, after which use of the substances is prohibited. Continued use is subject to authorisation approval from ECHA. The objective is the gradual substitution of high-risk substances.

3. Restriction List (Annex XVII) is a general restriction list that directly specifies restriction or ban conditions for substances with unacceptable risks. It applies to substances, mixtures and articles, directly limiting their placing on the market or use (e.g., concentration limits, banned application scenarios). It serves as a mandatory compliance baseline; non-compliance will result in sales bans or penalties.

1. Chemical industry: cosmetics, cleaners, coatings, adhesives, plastics, polymers, synthetic materials, etc.

2. Manufacturing industry: metal processing, electronics manufacturing, automobile manufacturing, textile production, furniture manufacturing, etc.

3. Construction industry: building materials, paints, coatings, thermal insulation materials, etc.

4. Consumer goods: toys, stationery, apparel, footwear, household goods, etc.

5. Healthcare industry: medical devices, pharmaceuticals, personal protective equipment, etc.

Registration: Registration constitutes the primary obligation under this regulation. Registrants must be legal entities established within the EU. After an enterprise successfully submits a registration dossier for a chemical substance to the European Chemicals Agency (ECHA), it will obtain an 18-digit registration number. Enterprises that fail to complete registration by the relevant deadline may no longer place the corresponding products on the EU market. Depending on whether a substance is included in the European Inventory of Existing Commercial Chemical Substances, registrations are categorized into two types: phase-in substance registration and non-phase-in substance registration.

Evaluation: Evaluation is conducted by the European Chemicals Agency and comprises two categories: Dossier Evaluation and Substance Evaluation. According to assessments by EU evaluation authorities, approximately 27,000 chemical enterprises will be affected by the REACH Regulation, and around 30,000 substances will fall under its scope.

Authorisation: For substances listed in Annex XIV of the REACH Regulation, the regulation establishes an authorisation regime governing their use and placing on the market.

Restriction of Chemicals: It sets out procedures to control the placing on the market and conditional or prohibited use of hazardous substances by manufacturers and importers. Examples include the ban on asbestos and restrictions on certain azo dyes.

Enforcement Bodies: Competent authorities of each EU Member State (customs, environmental protection authorities, market surveillance authorities). Each country formulates its own detailed penalty provisions.

Common Enforcement Scenarios: Random customs inspections upon import, market sampling tests, consumer complaints and reports, and competitor reports.

Penalty Measures: Detention of goods, return of shipments, mandatory destruction of products, EU-wide product withdrawal, public recalls, and administrative fines (which vary widely among Member States, up to several million euros; some Member States impose criminal liability for serious violations).