What is REACH Regulation?
REACH is the Regulation (EC) NO 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force on 1 June 2007 and applied on 1 June 2008. It becomes a harmonised regulation concerning preventative administration on all chemicals to be placed on the EU market superseding more than 40 directives and regulations for chemical management. The implementation of the regulation materially impacts the export to the European Union especially that of chemicals, electromechanical products, textiles, printing and dyeing, rubber, plastics, toys and furniture, etc.
What is the Scope of REACH Regulation?
Now REACH registration is required for all substances manufactured in EU or imported into EU in quantities of one tonne or more per year. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal conditions of use. The last REACH registration deadline is 31 May 2018 for all >=1t/y substances.
For all registrations, a registration dossier has to be prepared and submitted electronically via REACH-IT to the European Chemicals Agency (ECHA). Normally, the registration must be successfully completed and a REACH registration number assigned to the registrant before a substance can be manufactured, imported or placed on the market.
Which substances need to be registered under REACH?
Registration is required for all substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer unless they are exempted. For polymers, monomers shall be registered.
The following substances are exempt from REACH registration:
- Substances exempted from REACH regulation: radio-active substances, substances under customs supervision, substances used for national defense, non-isolated intermediates, wastes, etc.;
- Substances regulated by other legislation: substances in food, medicinal products, plant protection products, etc.;
- Substances in REACH annex VI: a list of exempt substances well-known to be safe (i.e., water, nitrogen);
- Substances covered by REACH annex V: by-products, naturally occurring substances, impurities, etc.;
How to Demonstrate Product Compliance with EU REACH?
If you product is a chemical product (substance or mixture), you need to ensure that every substance in it has been registered under EU REACH when the volume of that substance exceeds 1t/y. The best way to show compliance is to obtain a REACH registration number issued by the European Chemicals Agency (ECHA).
If your product is an article (i.e., clothes, toys, electrical appliances), you most likely need to check if your product contains any substance of very high concern(SVHC) and any substances on REACH annex XVII restricted substance list. Most of buyers probably do not want to buy any article containing a SVHC more than 0.1%w/w or any article that does not meet REACH restriction conditions.