What is REACH?
- REACH is the European Chemicals legislation. REACH compliance is complicated.
- Most of the chemicals marketed in the EU are subject to REACH Registration.
- For Substances of Very High Concern (SVHC) strict rules apply.
- Extended Safety Data Sheets and REACH notifications to ECHA are also REACH requirements.
GLIMPSE of REACH AT ELC
R E A CH = Registration Evaluation Authorisation Chemicals
REACH is the European chemicals legislation. It is applicable in all 27 EU countries along with Norway, Iceland and Liechtenstein. REACH legislation is not followed in Switzerland.
Registration involves submitting a vast technical dossier with toxicological and eco-
toxicological information, risk assessment, recommendations on how to manage the identified risks, proposals for classification and labelling etc.
Every substance marketed in EU in a quantity of more than 1 ton per manufacturer or importer per year, must be registered.
Only European legal entities are entitled for registration i.e., European chemical manufacturers, European importers and the ‘Only Representatives’ for non-European chemical manufacturers or formulators.
More information on our dedicated web page ‘REACH Registration services’.
ECHA (European Chemical Agency) introduced scheme of extended registration deadline by prioritizing substance registration based on tonnage and toxicity.
The process begins with a declaration known as a pre-registration, which is made to ECHA. By 1 December 2008 all companies manufacturing or importing a substance into the EU at 1 tonne or more per annum and who wished to take advantage of the extended registration deadline scheme should have pre-registered that substance with ECHA.
Potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year after 1 December 2008, can submit a late pre-registration if they met both criteria
At the latest 6 months after manufacturing or importing a substance above the 1 tonne threshold per year; and
At least 12 months before the relevant transitional deadline for registration.
Once late pre-registered manufacturers/importers can take advantage of the phased deadlines set by ECHA for registration.
Forgot to pre-register? Contact us we will find a solution.
More information on our dedicated web page ‘REACH Pre-registration services’.
Dossiers for large volume substances (> 100 tons per year) may be evaluated by respective Member State authorities.
As a result of this evaluation, registrants may be asked to revise parts of their registration dossier.
The REACH Authorisation addresses Substances of Very High Concern. The substances subject to Authorisation are listed in REACH Annex XIV. This annex is regularly expanded.
A manufacturer or importer of this substance must obtain a permit for using a substance subject to REACH authorisation. Permits are very difficult to get.
More information on our dedicated web page ‘REACH SVHC compliance services’.
Other REACH obligations
REACH also brings about many smaller obligations. For example: Extended Safety Data Sheets, requirements for users of chemicals and notification to ECHA of certain substances in ‘articles’ (objects).
Scope & REACH exemptions
All the substances marketed in quantities over 1 tonne per year (per legal entity), are in scope of REACH, unless they are explicitly exempted.
The biggest exemption is Polymers. But this is not as good as it sounds! The polymers themselves are indeed exempted, but the monomers and most of the additives that were used to make them, are not.
Also exempted: several groups of substances that are already well regulated or well known. For example: biocidal products, radioactive substances, minerals, food and waste.
For two specific end-uses, the REACH registration dossier need not cover the exposure to consumers: Cosmetics and Food Contact Materials.
Imports and REACH Only Representative
REACH only addresses European companies: EU-based manufacturers and EU-based importers. Companies based outside the EU cannot themselves do registrations, notifications or whatever is necessary for REACH compliance.
In the case of exports to the EU the following applies:
- Default: the EU-based importer of the goods is fully responsible for REACH compliance.
- Alternative: a REACH Only Representative is appointed by the non-EU producer.
The REACH Only Representative takes over most of the REACH obligations from the importer. The importer becomes a ‘Down Stream User’; as if he buys the products in the EU.
More information on our dedicated web page ‘REACH Only Representative services’