REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than 1t/year to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration under REACH; however, non-EU companies may submit REACH registration by appointing an Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.
The Scope of REACH Registration
Substances manufactured/imported above 1t/y on its own or in preparations; (Note: some substances are exempted).
Substances in articles if present above 1 t/y and intended for release (for example, ink in a pen);
Monomer substances if present at a concentration above 2% in a polymer (for polymers, monomers shall be registered);
Intermediates-reduced requirements and lower cost;
Substances subject to Product and Process Oriented Research and Development (PPORD) exempted from registration for 5 years; However, PPORD notification needs to be submitted.
Who Shall Submit REACH Registrations
Manufacturers/Importers in EU;
REACH only representative appointed by non-EU manufacturers;
The Deadline of REACH Registration
Substances can be categorized into two groups under REACH: phase-in substances and none phase-in substances. Each group has different REACH registration deadline.
Phase-in substances (existing substances) enjoy benefits of extended registration deadlines if pre-registered before Dec 2008. The principle is that the higher the tonnage, the earlier the registration deadline.
None phase-in substances (new substances not covered by the definition of a phase in substance) need to be registered immediately before being placed in the EU market.
Definition of Phase-in Substance
A substance which meets at least one of the following criteria:
It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
It was manufactured in the Community, or in the countries accepted to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.
It was placed on the market in the Community, or in the countries accepted to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.
Phase-in substances that missed pre-registration cannot enjoy benefits of extended registration deadline and shall be registered immediately.
Non-EU companies may submit registration by appointing an EU-based Only Representative to register on their behalf, an Only Representative must be an EU-based legal entity that has a sufficient background in the practical handling of substances and the information related to them required by the REACH regulation. Importers will be exempt from REACH registration if their non-EU suppliers have registered. However, importers need to confirm with their suppliers' Only Representative that they are included in the importer list and their tonnage and uses are covered by the OR.
More about REACH Only Representative
Chemical Inspection and Regulation Service (CIRS) is a leading product safety and chemical management consulting firm providing valued product regulatory compliance service, tailored solutions and original information to help clients gain competitive advantage by reducing business risks associations with regulatory affairs and removing barriers to entry. CIRS has provided cost-effective regulatory support to over 3,000 companies while doing businesses in both the EU and China. Since 2007, we have:
pre-registered over 10,000 substances;
registered over 2,000 substances;
served as lead registrant (LR) for over 200 substances;
prepared over 5,000 REACH SDS and CLP labels to date;
acted as only representative for over 3,000 non-EU companies;
served clients in more than 25 countries;
- Only Representative (OR) Service;
- Lead Registrant;
- Joint Submission;
- Dossier Evaluation/Updating;
- Chemical Safety Report (CSR) Compilation;
- Testing Coordination/Supervision;
- Alternative methods (QSAR, Read-Across, In-vitro, Grouping, etc.);
- SIEF Management Service;
- Development of Exposure Scenario (ES);
- REACH Technical Training Service